Decision of the Council of the Eurasian Economic Commission from 12.02.2016 N 46
(ed. from 30.03.2023)
«On the Rules of registration and examination of safety, quality and effectiveness of medical devices»

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COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

DECISION

dated February 12, 2016. N 46

ABOUT THE RULES

REGISTRATION AND EXAMINATION OF SAFETY, QUALITY

AND EFFECTIVENESS OF MEDICAL DEVICES

List of amending documents (ed. decisions of the Council of the Eurasian Economic Commission from 24.12.2021 N 144, from 19.05.2022 N 84, from 30.03.2023 N 50)

In accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, paragraphs 2 and 4 of Article 4 of the Agreement on Uniform Principles and Rules of Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, paragraph 92 of Annex N 1 to the Regulations of the Eurasian Economic Commission, approved by the Decision of the Supreme Eurasian Economic Council of December 23, 2014 N 98, and in order to implement the decision of the Supreme Eurasian Economic Council of 23

1. To approve the attached Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices (hereinafter referred to as the Rules).

2. Repealed. — Decision of the Council of the Eurasian Economic Commission from 30.03.2023 N 50.

3. Member States until December 31, 2016:

(a) Approve the amount of fees (duties) or other mandatory payments provided for by the Rules, taking into account the complexity of the procedures and the volume of work performed in the reference State and States of recognition, including at:

medical device registration;

examination of the safety, quality and efficacy of a medical device;

making amendments to the registration dossier of a medical device;

issuance of duplicate registration certificates;

b) to determine the bodies (organizations) responsible for the implementation of registration, amendments to the registration dossier and other procedures related to the registration of medical devices provided for by the Rules, and to inform the Eurasian Economic Commission about it .

4. This Decision shall enter into force upon expiration of 10 calendar days from the date of entry into force of the Protocol signed on December 2, 2015, on the accession of the Republic of Armenia to the Agreement on Uniform Principles and Rules of Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union dated December 23, 2014, but not earlier than upon expiration of 10 calendar days from the date of official publication of this Decision.

Members of the Council of the Eurasian Economic Commission:

From the Republic of ArmeniaV. GABRIELYAN

FROM the Republic of BelarusV. MATYUSHEVSKY

From the Republic of KazakhstanB. SAGINTAEV

From the Kyrgyz RepublicO. PANKRATOV

From the Russian FederationI. SHUVALOV

Approved

By the decision of the Council of the Eurasian

economic commission

dated February 12, 2016. N 46

RULES.

REGISTRATION AND EXAMINATION OF SAFETY, QUALITY

AND EFFECTIVENESS OF MEDICAL DEVICES

List of amending documents(ed. decisions of the Council of the Eurasian Economic Commission from 24.12.2021 N 144, from 30.03.2023 N 50)

I. General provisions

1. These Rules are developed in accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014 and paragraph 2 of Article 4 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014 and establish the procedure for registration and expert examination of the safety, quality and effectiveness of medical devices (hereinafter — examination), coordination of the expert opinion, settlement of disagreements in the

The requirements of this Regulation may not apply to medical devices, the need for which arises or increases in emergency situations, in conditions of hostilities, threat of spread of new epidemic diseases that pose a danger to others, under the threat of absence or unavailability of medical devices on the markets of the Member States of the Union (hereinafter — Member States) in conditions of introduction of restrictive economic measures in respect of at least one of the Member States. Circulation of such medical devices on the territories of the Member States shall be regulated by the legislation of these Member States during the validity of these conditions and elimination of their consequences.

(in edition of the decision of the Council of the Eurasian Economic Commission from 30.03.2023 N 50)

2. For the purposes of these Regulations, the terms used shall mean the following:

«safety of medical devices» — absence of unacceptable risk associated with harm to life, human health, environment;

«validation» — confirmation by providing objective evidence that the requirements intended for a particular use or application have been met;

«verification» — confirmation based on the provision of objective evidence that the established requirements have been met;

«State of recognition» — the Member State whose authorized body (expert organization) carries out the procedure of coordination of the expert opinion of the reference State;

«evidence of the first party» — evidence materials (documents) of the medical device manufacturer (protocols of its own tests (studies), including those issued by testing laboratories (centers) accredited in the national accreditation system of the Member State, results of clinical application of the medical device and other materials);

«unified register of medical devices registered within the Eurasian Economic Union» — an electronic database of medical devices registered in accordance with these Rules;

«applicant» — the manufacturer of the medical device or its authorized representative;

«quality of a medical device» — the degree of compliance of a set of properties and characteristics of a medical device with the purpose set by the manufacturer;

«medical devices for in vitro diagnostics» means any instruments, apparatus, devices, equipment, materials, reagents, calibrators, control materials and other products used for medical purposes individually or jointly, as well as together with accessories and special software necessary for their intended use, and intended by the manufacturer for use in in vitro studies of human biological materials samples to obtain information regarding physiological or pathological

«model (brand) of a medical device» — a variant of execution of a medical device characterized by certain design and technological solutions and specific values of indicators of its target (functional) purpose;

«accessory» means an article, other than a medical device, intended by its manufacturer to be used in conjunction with one or more medical devices when used in accordance with their intended use;

«medical device manufacturer», «manufacturer» — a legal entity or a natural person registered as an individual entrepreneur responsible for the development and manufacture of a medical device, making it available for use on its own behalf regardless of whether the medical device is developed and (or) manufactured by this person or on its behalf by other person(s), and responsible for the safety, quality and effectiveness of the medical device;

«production site» means a territorially separate complex designed to perform the entire process of production of a medical device or certain stages thereof;

«registration dossier» means a set of documents and materials of the established structure submitted by the applicant during the procedures of registration and examination, approval of the expert opinion, amendments to the registration dossier (including in a notification procedure), issuance of a duplicate of the registration certificate of a medical device, approval of the expert opinion on the registered medical device, revocation (cancellation) of the registration certificate of a medical device, as well as originals and (or) copies of the medical device registration certificate, as well as the original and (or) copies of the medical device registration certificate.

«registration certificate» means a document of uniform form confirming the fact of registration of a medical device on the territory of one or more Member States;

«registration of a medical device», «registration» — the procedure of issuing by the authorized body of the reference state of the authorization to put a medical device into circulation on the territory of one or more member states;

«reference state» — a Member State chosen by the applicant, whose authorized body (expert organization) carries out registration and examination;

«authorized body» — a public authority of a Member State authorized to implement and (or) coordinate activities in the sphere of circulation of medical devices on the territory of this Member State;

«authorized organizations» — organizations included in the unified register of authorized organizations having the right to conduct research (testing) of medical devices for the purpose of their registration;

«authorized representative of the manufacturer» — a legal entity or a natural person registered as an individual entrepreneur, who are residents of a Member State and authorized by the manufacturer in accordance with a contract or other document provided for by the legislation of the Member States to represent its interests and bear responsibility with regard to the circulation of a medical device within the Union and the implementation of mandatory requirements for medical devices.

3. Registration of a medical device shall be a mandatory condition for its release into circulation on the territory of one or more Member States and shall be carried out by the authorized body of the reference state. At the same time, the same requirements shall be imposed on medical devices manufactured on the customs territory of the Union and imported into the customs territory of the Union from third states.

4. In order to register a medical device, an expert examination shall be conducted by an expert organization determined by the authorized body of the Member State (hereinafter referred to as the expert organization).

5. A document confirming the fact of registration of a medical device shall be a registration certificate drawn up in accordance with the form and rules according to Annex No. 1.

The registration certificate shall be issued indefinitely and shall be valid in the territory of one or more Member States.

6. The registered medical device shall comply with the General requirements for the safety and effectiveness of medical devices, requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 27 (hereinafter — the General Requirements). The manufacturer (authorized representative of the manufacturer) is responsible for compliance of medical devices with the General Requirements.

7. Manufacturers from third States shall designate an authorized representative of the manufacturer acting during the period of circulation of the medical device within the Union and keep up to date the information on such manufacturer’s representative contained in the registration dossier.

8. The manufacturer shall ensure the implementation and maintenance of the quality management system of the medical device in accordance with the Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices depending on the potential risk of their use, approved by the Decision of the Council of the Eurasian Economic Commission dated November 10, 2017. N 106 (hereinafter — Requirements for the quality management system).

9. Prior to submission to the authorized body (expert organization) of the reference state of an application for expert examination of a medical device and an application for registration of a medical device in the forms according to Annexes N 2 and 3 (hereinafter — applications for registration and expert examination), the applicant shall collect evidence of safety and efficacy of the medical device and prepare the relevant registration dossier.

10. In order to prepare the registration dossier, the applicant (if necessary):

a) has the right to apply to the authorized body (expert organization) for preliminary consultations on issues related to registration and examination, including on a reimbursable basis, in accordance with the procedure established by the authorized body (expert organization) of the relevant Member State;

b) in order to confirm compliance of the medical device with the General Requirements:

conducts technical tests, tests (studies) to assess the biological effect of the medical device, clinical and clinical-laboratory tests (studies) of the medical device or includes available data (first party evidence) in the registration dossier;

conducts tests for the purpose of type approval of measuring instruments (in respect of medical devices included in the list of types of medical devices to be classified as measuring instruments during their registration, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 42) in the order established by the legislation of the Member State in the field of ensuring uniformity of measurements, in the organizations selected by the applicant, authorized (notified) in accordance with the legislation of the Member State to conduct tests of measuring instruments;

c) ensure periodic (scheduled) or unscheduled inspection of production in order to assess production conditions and evaluate the manufacturer’s quality management system in accordance with the Requirements for Quality Management System.

11. During registration and examination, the authorized bodies (expert organizations) mutually recognize the results of tests (studies) specified in subparagraph «b» of paragraph 10 of these Rules, provided that they are performed in accordance with the Rules of technical testing of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 28, Rules for conducting research (tests) to assess the biological effect of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission on May 16, 2016. N 38, or the Rules for conducting clinical and clinical-laboratory tests (trials) of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 29, respectively, as well as the legislation of the Member State in the case of testing for the purpose of type approval of measuring instruments.

12. If necessary, the authorized body (expert organization) shall engage external experts to participate in the expert examination if their special knowledge is necessary for the expert examination.

Representatives of authorized organizations that have conducted tests (investigations) in relation to the medical device submitted for expert examination, specified in subparagraph «b» of paragraph 10 of these Rules, as well as representatives of inspection organizations that have assessed the quality management system (inspection of production) of the manufacturer of such medical device, may not be involved in the expert examination.

When conducting the expert examination, the expert shall be independent of the body or person who appointed the expert examination, the manufacturer, his authorized representative or other persons interested in the results of the expert examination.

In case the expert is aware of circumstances that prevent him/her from being involved in the expert examination or do not allow him/her to comply with the principles of its conduct, he/she shall inform the head of the authorized body (expert organization) of the reference state.

13. The applicant is responsible for the accuracy of the information provided in the registration dossier.

On the content and structure of documents of the registration dossier of a medical device and the examination of safety, quality and efficacy for the purposes of its registration within the EAEU, see Recommendation of the EEC Collegium of 23.12.2024 No. 27. Recommendation of the EEC Collegium of 23.12.2024 N 27.

Documents of the registration dossier shall be submitted in the Russian language in electronic form. If the legislation of the reference state does not provide for the possibility of execution of these documents in electronic form, the authorized body (expert organization) of the reference state has the right to request such documents (their copies) in hard copy.

If the documents of the registration dossier are submitted on paper, the applicant shall also provide electronic copies of them on an electronic medium (in *.pdf format with a text layer with the ability to select and copy text, as well as search). Electronic copies of documents must be submitted in accordance with the classifier of types of documents of the registration dossier of a medical device, approved by Decision of the Board of the Eurasian Economic Commission dated April 3, 2018 N 48.

The operating document or instructions for use of the medical device, the service manual and the text of the medical device labeling shall additionally be submitted in the state language(s) of the Member States if there are relevant requirements in the legislation of the Member States.

Documents of the registration dossier submitted in a foreign language shall be accompanied by a translation into Russian certified in accordance with the procedure established by the legislation of the reference state.

14. When calculating the period of time for conducting by authorized bodies (expert organizations) of the procedures provided for by these Rules, the following periods shall not be taken into account:

a) the period from the day of sending by the authorized body (expert organization) of the reference State to the applicant of a request or notification on the need to eliminate the identified violations and (or) submission of missing documents or on the need to submit copies of documents on payment for the procedure of coordination of the expert opinion in the State(s) of recognition to the day of receipt by the authorized body (expert organization) of the reference State of a response to such request or notification;

b) the period required to organize and conduct inspection of production (in the case of inspection of production within the framework of registration and examination procedures);

c) the period necessary for sending the report on the results of the inspection of production by the inspecting organization (in case its role is not performed by the authorized body (expert organization)) to the authorized body (expert organization) for inclusion in the registration dossier (in case of inspection of production within the framework of registration and examination procedures);

d) the period of agreement with the applicant on the need to apply to the Advisory Committee on Medical Devices under the Board of the Eurasian Economic Commission (hereinafter — the Advisory Committee).

15. Expenses for the registration and examination procedures, approval of the expert opinion, amendments to the registration dossier (including in a notification procedure), issuance of a duplicate of the registration certificate or approval of the expert opinion for the registered medical device shall be borne by the applicant in accordance with the legislation of the Member State.

16. Registration is effected by the reference State following examination and agreement of the expert report by the State(s) of recognition.

17. Authorized bodies (expert organizations) of the states of recognition have the right to get acquainted with the progress of expert examination in the reference state and relevant documents, including documents drawn up when the applicant submits additional and clarifying information in the process of registration and expert examination of a medical device.

18. Information on medical devices, in respect of which procedures provided for by these Rules are carried out, as well as documents contained in the registration dossier, except for the operating document or instructions for use of the medical device, service manual, data on labeling and packaging (full-color (with indication of color coding) layouts of packages and labels), text of labeling in Russian and state languages of the Member States, are classified as confidential information and are available only to interested parties.

19. Inclusion in one registration certificate of several models (brands) of a medical device, including those belonging to different types of medical devices in accordance with the nomenclature of medical devices applied in the Union, is possible provided that these models (brands) meet all the following criteria:

a) production of models (brands) of a medical device is carried out by one manufacturer according to one technical documentation;

b) models (brands) of the medical device belong to the same class of potential risk of use;

c) models (brands) of the medical device have the same functional purpose and principle of operation;

d) models (brands) of the medical device are designed to determine the presence and (or) quantitative content in a biological sample of the same clinically (diagnostically) significant analyte(s) (for medical devices for in vitro diagnostics);

e) models (brands) of the medical device have different configurations that do not affect the principle of operation and functional purpose, which allows for expansion or specialization of their use for medical purposes (by applicability);

e) models (brands) of the medical device have different technical parameters (e.g. radiation wavelength, size of the light field, resolution, etc.) that do not affect the principle of operation and functional purpose (by applicability);

g) models (brands) of a medical device form a size (model) range (for example, they have different dimensions (overall, linear, volumetric, etc.), shape, color coding, are made of the same materials, etc.) or are a group of medical device design (for example, a stationary mobile apparatus (device, system, complex, etc.) with wall and (or) floor mounting, etc.) (according to applicability). In this case, the group of medical device design means the products for which one group drawing of parts and (or) one group specification are made;

h) models (brands) of the medical device have the same features in part:

areas of application;

of invasiveness;

sterility (including sterilization methods);

frequency of use (single use, multiple use by a single patient, multiple use by multiple patients);

operational and design features;

duration of use;

similarity of materials used in modifications of a medical device and contacting the human body (in terms of their chemical, toxicological, physical, electrical, morphological and mechanical properties).

20. It shall not be allowed on the customs territory of the Union:

(a) Selection of two or more reference States for registration and examination of a single medical device;

b) registration of different medical devices under one name;

c) registration as medical devices products, the name of which is contained in the unified register of registered medicines of the Eurasian Economic Union, the procedure for the formation and maintenance of which is approved by the Decision of the Council of the Eurasian Economic Commission of November 3, 2016. N 84, or coincides with the name of a biologically active food supplement, information about which is contained in the unified register of certificates of state registration of products, the procedure for the formation and maintenance of which is approved by the Decision of the Board of the Eurasian Economic Commission of June 30, 2017. N 80. If a medicinal product or biologically active food supplement is a component of a medical product, their names may be used in the name of the medical product.

II. Procedures for registration and examination of a medical device

21. For the registration of a medical device, the applicant shall select a reference state and at least one state of recognition.

22. The applicant shall submit the following documents to the authorized body (expert organization) of the reference state:

a) registration dossier containing applications for registration and examination, as well as documents according to the list in Annex No. 4;

b) copies of documents confirming payment for registration and examination procedures in the reference state.

23. The authorized body (expert organization) of the reference state within 7 working days from the date of receipt of applications for registration and examination and documents specified in paragraph 22 of these Rules, shall verify the completeness and accuracy of the information contained in them.

24. If applications for registration and examination are submitted in violation of the requirements established by these Rules, or they contain unreliable information, or the documents specified in paragraph 22 of these Rules are not submitted in full, the authorized body (expert organization) of the reference state within 7 working days from the date of receipt of such applications and documents shall notify the applicant on the need to eliminate the identified violations and (or) submission of missing documents within 30 working days from the date of placement of the application and documents.

25. If after 30 working days the applicant has not eliminated the identified violations and (or) has not submitted missing documents, the authorized body (expert organization) of the reference state within 3 working days takes a decision to return to the applicant applications for registration and examination and documents with justification of the reasons for return.

26. Within 3 working days from the date of submission of applications for registration and examination and documents complying with the requirements of these Rules, as well as in case of elimination of the identified violations and (or) submission of documents complying with the requirements of these Rules within the period established in paragraph 24 of these Rules, the authorized body (expert organization) of the reference state makes a decision on the beginning of registration and examination procedures, as well as places in its information system the registration dossier containing the applications for registration and examination and the documents complying with the requirements of these Rules.

27. Examination includes (if applicable):

(a) Assessment of the correctness of the classification of the article as a medical device;

b) assessment of compliance with the class of potential risk of use of a medical device specified by the applicant in accordance with the Rules of classification of medical devices depending on the potential risk of use, approved by the Decision of the Board of the Eurasian Economic Commission of December 22, 2015 N 173;

c) assessment of the correctness of attributing a medical device (models (brands) of a medical device) to a certain type of medical devices in accordance with the nomenclature of medical devices, the rules for maintaining which are approved by the Decision of the Board of the Eurasian Economic Commission of December 29, 2015 N 177;

d) assessment of compliance of models (brands) of a medical device (if any) included in one registration certificate with the criteria established by Clause 19 of these Rules;

e) analysis and evaluation of evidentiary documents (materials) confirming compliance of the medical device with the General Requirements, including:

analysis of the information submitted by the manufacturer on compliance of the medical device with the General Requirements, including analysis of correct identification of the provisions of the General Requirements applicable to the medical device;

assessment of compliance of technical test protocols issued by authorized organizations with the Rules of technical testing of medical devices;

assessment of compliance of the protocols of research (tests) to assess the biological effect of medical devices, issued by authorized organizations, with the Rules for conducting research (tests) to assess the biological effect of medical devices;

analysis of the report on assessment of biological effect of a medical device (conducted, among other things, to confirm that materials coming into contact (interacting) with human tissues are identified (brands of materials and their manufacturers are specified), as well as to confirm the validity of the absence of the need to conduct studies (tests) to assess the biological effect);

analysis of the report on clinical evidence of efficacy and safety of the medical device (conducted to confirm the validity of the choice of methods for proving clinical efficacy and safety of the medical device, validity of the data used to prove clinical efficacy and safety of the medical device, as well as the validity of the conclusion on clinical efficacy and safety for all declared indications for use, taking into account the presence or absence of contraindications);

assessment of compliance of reports on clinical (clinical-laboratory) trials (research) of medical devices with the Rules for clinical and clinical-laboratory trials (research) of medical devices;

validity analysis of first party evidence (if any) to confirm compliance of the medical device with the General Requirements taking into account the class of potential risk of use of the medical device (for medical devices of classes of potential risk of use 2b and 3, the first party evidence shall be accompanied by a test (research) program and justification of the selected methods);

analyzing the standards used by the manufacturer in the design and manufacture of the medical device;

analysis of safety and efficacy of the medicinal product as part of a medical device, its effect on functionality of the medical device, compatibility of the medicinal product with the medical device (except for medical devices for in vitro diagnostics). The medicinal product must be registered and authorized for use in the state that is the manufacturer of the medicinal product;

analysis of biosafety data for a medical device based on the analysis of all materials of animal or human origin included in the medical device, information on source (donor) selection, material selection, processing, storage, testing, validation of testing procedures, and handling of tissues, cells, substances of animal or human origin, microbial and viral cultures;

Analysis of the procedure and methods of sterilization of a medical device, materials justifying the method of sterilization, proposed methods of quality control and determination of sterilizing agent residues when using the chemical method of sterilization;

study of software validity based on the analysis of data on its verification and validation, including information on its development, measures and means of protection against unauthorized access and cybersecurity, testing by the manufacturer, identification and marking data;

analyzing the report on the stability of the medical device, validity of the declared shelf life;

review of the risk analysis report in order to confirm the completeness of the hazards, hazardous situations and related risks identified in such report, which can be assessed as unacceptable, as well as to confirm the manufacturer’s conclusion that there are no unacceptable risks or the acceptability of risks that are assessed as acceptable in the risk analysis report based on the analysis of the risk-benefit ratio;

confirmation on the basis of the submitted evidence (documents) of the validity of the manufacturer’s assessment result on compliance of the medical device with the General Requirements;

assessment of compliance of the operating document or instructions for use, service manual with the General Requirements;

assessment of compliance of the medical device labeling with the General Requirements;

analyzing the requirements to the technical characteristics of a medical device;

evaluation of documents confirming the results of tests of medical devices for the purpose of type approval of measuring instruments (in respect of medical devices included in the list of types of medical devices subject to classification as measuring instruments during their registration);

f) analysis of reports on the results of inspection of medical device production (conducted in order to confirm the compliance of the declared medical device to the group (subgroup) of medical devices, taking into account the class of potential risk of use according to Annex N 2 to the Requirements to the Quality Management System, as well as to confirm the reliability of information on the production sites specified in the applications for registration and examination, which are covered by the report on the results of inspection of medical device production

g) analysis of data on quality management system certification (if any), including requirements for compliance with which the manufacturer’s quality management system is certified, and information on certificates (number, date of issue, certificate validity period, name and information on accreditation of the certification body);

h) confirmation of the validity of the indication of the production sites of the medical device to be registered;

(i) Analysis of data on the development and production of the medical product (flow diagrams of the manufacturing processes, information on the main stages of production, packaging, testing and the procedure for the final product);

j) analyzing the marketing information provided by the manufacturer;

k) analysis of information submitted by the manufacturer on the presence or absence of reports of adverse events and (or) accidents related to the use of medical device, recalls of the medical device from the market, notifications on the safety of the medical device, approaches to solving such problems by the manufacturer when they occur, description of corrective actions taken, as well as analysis of the ratio of the level of sales, number of accidents and recalls of the medical device from circulation;

(m) Analyzing the plan for collecting data on the safety and efficacy of the medical device at the post-marketing stage.

28. When conducting an expert examination, in case of insufficiency of materials and information contained in applications for registration and examination and documents of the registration dossier to make a decision on the commencement of inspection of production (if it is necessary to conduct it) or to prepare an expert report (if there is no need to conduct inspection of production), the authorized body (expert organization) of the reference state sends to the applicant an appropriate request (indicating the nature of the comments and the ways of their assimilation). The request is sent once by the method specified in the applications for registration and examination.

The applicant shall be obliged to submit a response to the request within 60 working days from the date of its receipt. In case of failure to submit the said response within the deadline, the authorized body (expert organization) shall make a decision on the possibility of registration of the medical device on the basis of the documents at its disposal.

If the authorized body (expert organization) of the reference state reveals in the documents submitted by the applicant in response to the request inaccurate data or documents composed or containing text in a foreign language without translation into Russian certified in accordance with the procedure established by the legislation of the reference state, the authorized body (expert organization) within 2 working days from the date of receipt of such documents shall deliver to the applicant in the manner specified in the application for registration and examination, the decision to return the documents to the applicant.

29. The authorized body (expert organization) of the reference state shall, within 45 working days from the date of its decision to initiate the procedures for registration and expert examination of a medical device, issue an expert opinion in accordance with Annex No. 5 or, if it is necessary to inspect the production, make a decision to initiate the inspection of the production (provided that there are no remarks to the documents contained in the submitted dossier or the remarks specified in the request are eliminated) and notify the applicant of the decision made.

30. When making a decision on the start of inspection of production by the authorized body (expert organization) of the reference state, the inspecting organization of the reference state conducts inspection of production in accordance with the Requirements for the quality management system. The period of organization and carrying out of inspection of production shall not exceed 90 working days from the date of adoption by the authorized body (expert organization) of the decision to start inspection of production.

31. The report on the results of production inspection shall be sent by the inspecting organization to the authorized body (expert organization) of the reference state for inclusion in the registration dossier and to the applicant by registered mail with acknowledgement of receipt or in the form of an electronic document signed with an electronic signature within 15 working days from the date of completion of production inspection. In this case, if the results of production inspection revealed non-compliances, the report on the results of production inspection, supplemented with information on elimination of identified non-compliances, shall be sent by the inspecting organization to the authorized body (expert organization) of the reference state within 15 working days after receipt from the applicant of information on elimination of non-compliances or from the date of expiry of the period set for their elimination.

In the event that, based on the results of production inspection, changes are made in the documents of the registration dossier for the registered medical device, such documents, drawn up in accordance with Annex No. 4, shall be sent by the inspecting organization to the authorized body (expert organization) of the reference state.

32. The authorized body (expert organization) of the reference state within 15 working days from the date of receipt of the report on the results of production inspection draws up an expert opinion in accordance with Annex N 5 to these Rules.

33. The conclusions contained in the expert report shall be unambiguous and understandable.

34. The grounds for issuance by the authorized body (expert organization) of the reference state of a conclusion on refusal to register a medical device are:

a) failure to confirm the quality, and (or) efficacy, and (or) safety of the medical device with the relevant materials and information contained in the registration dossier;

b) exceeding the risk of harm to the health of citizens and medical workers due to the use of a medical device over the effectiveness of its use;

c) detection of unreliable data on efficacy and safety of a medical device and their inconsistency with the data on the medical device contained in the documents of the registration dossier during the implementation by the authorized bodies of the state control (supervision) over the circulation of medical devices.

35. If the expert opinion regarding the possibility of registration of a medical device is negative, the authorized body (expert organization) shall, within 10 working days from the date of execution (receipt) of the expert opinion, take a decision to refuse registration of the medical device, draw up and issue to the applicant in the manner specified in the application for registration and expert examination a notice of refusal to register the medical device with justification of the reasons for the refusal and attach to it a copy of the expert opinion of the authorized body (expert organization).

36. In case the expert opinion on the possibility of registration of medical device is positive, the authorized body (expert organization) of the reference state within 5 working days from the date of registration of the expert opinion shall place the registration dossier and this expert opinion in its information system and notify the applicant on the necessity to submit copies of documents on payment for the procedure of coordination of the expert opinion in the state (states) of recognition within 30 calendar days.

37. The applicant shall notify the authorized bodies (expert organizations) of the reference State and the State(s) of recognition of the payment for the coordination procedures within the time limit established by paragraph 36 of this Regulation.

38. Approval of the expert opinion shall be the basis for making a decision on registration of the medical device in the State of recognition and shall be executed by the authorized body (expert organization) of the State of recognition in the form of a conclusion on confirmation of approval (non-approval) of the expert opinion according to Annex No. 6 (hereinafter — confirmation of approval (non-approval) of the expert opinion).

39. Coordination of the expert report by the authorized body (expert organization) of the State of recognition shall be carried out in accordance with Section III of these Rules.

40. Provided that there are no disagreements between the reference State and the State(s) of recognition regarding the agreement of the expert report, the authorized body (expert organization) of the reference State:

(a) Within 10 working days from the date of receipt from all authorized bodies (expert organizations) of the States of recognition of confirmation of the agreement of the expert report or from the date of expiry of the period established for the provision by the States of recognition of the said confirmation (provided that the applicant has submitted to the authorized body (expert organization) of the reference State copies of documents on payment for the procedure of agreement of the expert report in the States of recognition and translations of the operational document or and and

b) within 10 working days from the date of making a decision on registration of a medical device, shall execute and issue a registration certificate and its annex to the applicant in the manner specified in the application for registration of the medical device.

41. Non-agreement of the expert opinion of the authorized body (expert organization) of the reference state in one of the states of recognition is a ground for refusal to register a medical device in the territory of this state of recognition.

42. In case there is a State (States) of recognition whose authorized body (expert organization) has not agreed the expert opinion, the authorized body (expert organization) of the reference State shall, within 10 working days from the date of receipt from all authorized bodies (expert organizations) of the States of recognition of confirmation of agreement (non-agreement) of the expert opinion or from the date of expiry of the time limit set for provision by the States of recognition of the said confirmation (provided that the State(s) of recognition has not agreed the expert opinion).

a) send to the applicant a notification on the need to agree the application to the Advisory Committee to resolve disagreements regarding the agreement of the expert opinion, with a copy (copies) of the confirmation of the agreement (non-agreement) of the expert opinion. In the absence of the applicant’s response after 15 working days from the date of receipt of the relevant notice, the application to the Advisory Committee shall be considered uncoordinated;

b) in case of agreement with the conclusions of the authorized body (expert organization) of the state of recognition about impossibility to register the medical device, shall take a decision to refuse to register the medical device. In this case, the authorized body (expert organization) of the reference state shall, within 10 working days from the date of taking the decision to refuse registration of the medical device, execute and issue to the applicant in the manner specified in the application for registration and expert examination a notice of refusal to register the medical device (with justification of the reasons for refusal and enclosing copies of the expert opinion and confirmation of disagreement of the expert opinion).

43. The authorized body (expert organization) of the reference state within 3 working days from the date of receipt of the response from the applicant regarding the application to the Advisory Committee for settlement of disagreements regarding the expert opinion:

(a) Apply to the Advisory Committee in accordance with Section IV of these Rules (if the applicant has agreed to apply to the Advisory Committee);

b) takes a decision on registration of a medical device without indication in the registration certificate of the state (states) of recognition, the authorized body (expert organization) of which did not agree with the expert opinion (in case of non-agreement of the applicant’s application to the Advisory Committee). In this case, the authorized body (expert organization) of the reference state within 10 working days from the date of the decision on registration of the medical device:

places in the unified register of medical devices registered within the Union the information on the medical device provided for by the Procedure for the formation and maintenance of the information system;

draws up and issues a registration certificate and its annex to the applicant in the manner specified in the application for registration of a medical device.

III. Procedure for approval of the expert opinion

44. The procedure for approval of an expert opinion shall be carried out in respect of an expert opinion drawn up under the following procedures:

(a) Procedures for registration and examination of the medical device in accordance with Section II of these Regulations;

b) the procedure for amendments to the registration file in accordance with Section V of this Regulation;

c) procedure for approval of the expert opinion on the registered medical device in accordance with Section VIII of these Regulations.

45. The applicant, within the period agreed with the authorized body (expert organization) of the state of recognition and not exceeding the period specified in paragraph 50 of these Rules, shall ensure submission to the authorized body (expert organization) of the reference state and the state of recognition of translations of the operating document or instructions for use of the medical device, service manual and labeling text into the state language of the state of recognition (if there are corresponding requirements in the legislation of the state of recognition).

46. When conducting the procedure for approval of the expert opinion, the authorized body (expert organization) of the state of recognition shall assess completeness and sufficiency of data confirming safety, quality and effectiveness of the medical device, correctness of translation of the operating document or instructions for use of the medical device, service manual and labeling text into the state language of the state of recognition (if necessary).

47. If necessary, the authorised bodies (expert organisations) of the recognizing States may send their comments and proposals to the authorised body (expert organisation) of the reference State using the means of the integrated information system of the Union (hereinafter referred to as the integrated system) before the authorised body (expert organisation) draws up an expert opinion.

48. In the course of coordination of the expert opinion the authorized bodies (expert organizations) of the Member States may interact with each other in order to settle arising issues.

49. In case of disagreement between the reference State and the State(s) of recognition regarding the agreement of the expert report, the authorized body (expert organization) of the reference State shall take a decision on the basis of the expert report and confirmation of disagreement of the expert report, including taking into account the results of the settlement of disagreements regarding the agreement of the expert report within the Advisory Committee (in case of application to the Advisory Committee).

50. The authorized body (expert organization) of the State of recognition shall consider the expert report within 30 working days, calculated from one of the following dates:

during the procedures of registration and examination of a medical device — from the date of receipt by the authorized bodies (expert organizations) of the reference state and state(s) of recognition of the notification of payment for the approval procedures;

when conducting the procedure for making changes to the registration dossier — from the date of placement by the authorized body (expert organization) of the reference state in its information system of the registration dossier containing the application for amendments to the registration dossier;

when conducting the procedure for approval of the expert opinion on the registered medical device — from the date of placement by the authorized body (expert organization) of the reference state in its information system of the registration dossier containing the application for approval of the expert opinion on the registered medical device.

In this case, the condition for the calculation of this term is the availability on the account of the authorized body (expert organization) of the State of recognition of funds received as a result of payment by the applicant for the procedure of coordination of the expert opinion in the State of recognition in full.

51. According to the results of consideration of the expert opinion, the authorized body (expert organization) of the state of recognition sends to the authorized body (expert organization) of the reference state the confirmation of agreement (non-agreement) of the expert opinion (with justification) using the means of the integrated system (including confirmation of the correctness of translation of the operating document or instructions for use of the medical device, service manual and labeling text into the state languages, including confirmation of the accuracy of the translation of the operating document or instructions for use of the medical device, service manual and labeling text into the state languages).

52. In case of non-submission by the state of recognition of confirmation of approval (non-approval) of the expert opinion within the term established by paragraph 50 of these Rules, the expert opinion shall be deemed to be agreed provided that the applicant has submitted to the authorized bodies (expert organizations) of the reference state and the state of recognition translations of the operating document or instructions for use of the medical device, service manual and labeling text into the state language of the state of recognition.

53. Within the framework of the procedures for registration and expert examination of a medical device in accordance with Section II of these Rules, the grounds for non-approval by the state of the recognition of an expert opinion shall be:

(a) The grounds provided for in paragraph 34 of this Regulation;

b) failure by the applicant to provide translation of the operating document or instructions for use of the medical device, service manual and labeling text into the official language of the State of recognition (if necessary) within the agreed period of time;

c) absence on the account of the authorized body (expert organization) of the state of recognition of monetary funds received as a result of payment by the applicant for the procedure of coordination of the expert opinion in full.

54. Within the framework of the procedure for approval of the expert opinion on the registered medical device in accordance with Section VIII of these Rules, the grounds for non-agreement of the state to recognize the expert opinion shall be the grounds stipulated in paragraph 34 of these Rules.

55. In the procedure for amendments to the registration dossier under Section V of these Rules, the grounds for non-approval by the State of the recognition of an expert report are:

(a) The grounds provided for in paragraph 79 of this Regulation;

b) absence of translations of the operating document or instructions for use of the medical device, service manual and labeling text into the official language of the State of recognition (if necessary).

IV. Settlement of disagreements regarding harmonization expert report

56. In the absence of consensus on the issue of approval of the expert opinion drawn up within the framework of the procedures for registration and examination of a medical device in accordance with Section II of these Rules, the settlement of disagreements shall be carried out through an application of the authorized body (expert organization) of the reference state to the Advisory Committee.

57. The authorized body (expert organization) of the reference state, in agreement with the applicant, shall send to the Advisory Committee a statement on the need to consider the disagreement (indicating information on the subject of disagreement and on the results of negotiations and consultations). The statement may be accompanied by any materials justifying the position of the authorized body (expert organization) of the reference state on the subject of disagreement.

58. Upon receipt of the application and attached materials from the authorized body (expert organization) of the reference State, the Advisory Committee shall request from the authorized bodies (expert organizations) of the recognizing States materials confirming their position on the subject of the disagreement.

59. The Advisory Committee shall send notification of the disagreement settlement meeting to the authorized bodies (expert organizations) of the reference State and the recognizing States after they have submitted the relevant materials.

60. The organization and holding of the meeting on settlement of disagreements shall be provided by the Advisory Committee. Members of the Advisory Committee who are representatives of the authorized bodies (expert organizations) shall participate in the meeting. If necessary, at the suggestion of the authorized bodies, representatives of health care organizations, expert organizations, manufacturer and other specialists may be invited to participate in the consideration of of the issue discussed at the meeting of the Advisory Committee.

61. Following the meeting of the Advisory Committee, a decision shall be adopted, which shall be of a recommendatory nature.

62. The term of settlement of disagreements regarding the agreement of the expert opinion shall not exceed 30 working days from the date of sending by the authorized body (expert organization) of the reference state to the Advisory Committee of the relevant application and materials.

63. Within 3 working days from the date of receipt of the minutes of the meeting of the Advisory Committee for the settlement of disagreements, the authorized body (expert organization) of the reference state, based on the recommendations of the Advisory Committee, shall make a decision on the possibility of registration of the medical device.

64. If the decision taken in accordance with paragraph 63 of these Rules is positive, the authorized body (expert organization) of the reference state within 3 working days from the date of its adoption:

a) place in the unified register of medical devices registered within the Union the information on the medical device provided for by the Procedure for the formation and maintenance of the information system;

b) draws up a registration certificate and its annex (indicating the states of recognition, authorized bodies (expert organizations) of which the expert opinion has been agreed upon) and issues them to the applicant in the manner specified in the application for registration of a medical device;

c) if, following a meeting of the Advisory Committee, there is a State (States) of recognition whose authorized body (expert organization) did not agree on the expert opinion, sends to the applicant in the manner specified in the applications for registration and examination a notification of the decision of the authorized body (expert organization) of the State of recognition (attaching a copy of the confirmation of non-agreement of the expert opinion and the decision (protocol record) of the Advisory Committee).

65. If the decision taken in accordance with paragraph 63 of these Rules is negative, the authorized body (expert organization) of the reference state shall, within 3 working days from the date of its adoption, execute and issue to the applicant in the manner specified in the applications for registration and examination, a notice of refusal to register the medical device (with justification of the reasons for refusal and attachment of copies of the expert opinion, confirmation of disagreement of the expert opinion and the decision (protocol record) of the Advisory Committee).

V. Procedure for amendments to the registration file

66. The applicant must initiate a process to amend the documents contained in the registration dossier within 90 calendar days of the amendment of the registration dossier.

67. Changes to the registration dossier that require registration of a new medical device include:

a) changes entailing a change in the functional purpose and (or) principle of operation of the medical device;

b) inclusion of information on models (brands) of the registered medical device that do not meet the criteria for inclusion of several models (brands) of the medical device in one registration certificate in accordance with paragraph 19 of these Rules;

c) changes entailing simultaneous change of information on the manufacturer and production site(s) in relation to the information specified in the registration certificate issued as part of the procedures for registration and examination of a medical device, except for information on the legal form, address, reorganization, other information contained in the statutory documents.

68. In the event of amendments resulting in changes in the operating document or instructions for use of the medical device, service manual and labeling text, within 180 calendar days from the date of such changes, the release into circulation of medical devices corresponding to the documents and information from the registration dossier prior to the amendments shall be allowed. Simultaneous release into circulation of medical devices with an operating document or instructions for use of the medical device, service manual and labeling text corresponding to the documents and information from the registration dossier before and after making changes therein is allowed.

69. The procedure for making amendments to the registration dossier (except for amendments for which there is a notification procedure) requires the procedure for coordinating the expert report with the States of recognition specified in the registration certificate in accordance with the procedure established in section III of these Regulations.

70. In order to make changes in the registration dossier, the applicant shall send the following documents and information to the authorized body (expert organization) of the reference state:

a) application for amendments to the registration dossier (on paper and/or electronically) in the form according to Annex No. 7 (hereinafter in this section — application for amendments);

b) copy of the document confirming the powers of the manufacturer’s authorized representative (if any);

c) documents and information on the relevant changes, including documents confirming the changes and certifying that the introduction of these changes does not entail changes in the properties and characteristics of the medical device affecting its safety, quality and effectiveness, or improves its properties and characteristics while keeping the functional purpose and (or) principle of operation of the medical device unchanged;

d) copies of documents confirming payment for the procedure of amendments to the registration dossier in the reference state and the procedure of approval of the expert opinion in the state (states) of recognition, as well as issuance of the registration certificate in the reference state (if necessary);

e) original registration certificate (duplicate);

(e) Inventory of documents.

71. The authorized body (expert organization) of the reference state within 7 working days from the date of receipt of the application for amendments, as well as documents and information specified in paragraph 70 of these Rules, shall verify the completeness and accuracy of the information contained therein.

72. If an application for amendments is submitted in violation of the requirements of these Rules and (or) contains unreliable information and (or) the documents and information specified in paragraph 70 of these Rules are not submitted in full, the authorized body (expert organization) of the reference state within 7 working days from the date of receipt of such application, documents and information shall notify the applicant of the need to eliminate the identified violations and (or) submission of missing documents within 30 working days from the date of placement of the application, documents and information from the reference state.

73. If after 30 working days the applicant has not eliminated the identified violations and (or) has not submitted missing documents, the authorized body (expert organization) of the reference state within 3 working days makes a decision to return the application for amendments and documents (with justification of the reasons for return).

74. Within 3 working days from the date of submission of the application for amendments, documents and information complying with the requirements of this Regulation, as well as in case of elimination within 30 days of the identified violations and (or) submission of documents complying with the requirements of this Regulation, the authorized body (expert organization) of the reference state makes a decision on the beginning of the procedure of amendments to the registration dossier and places in its information system the registration dossier containing the application for amendments to the registration dossier.

75. During the examination, in case of insufficiency of materials and information contained in the application for changes and documents confirming the changes, the authorized body (expert organization) of the reference state sends the applicant a corresponding request (indicating comments and ways to eliminate them). The request is sent to the applicant once by the method specified in the application for changes.

The applicant shall provide a response to the request within 60 working days from the date of its receipt. In case of failure to provide a response within the specified period, the authorized body (expert organization) of the reference state shall make a decision on the basis of the documents at its disposal.

76. If the authorized body (expert organization) of the reference state identifies inaccurate information in the documents submitted by the applicant in response to the request, or documents composed or containing text in a foreign language without a translation into the Russian language certified in accordance with the procedure established by the legislation of the Member State, the authorized body (expert organization) of the reference state shall, within 2 working days from the date of receipt of such documents, deliver to the applicant in the manner specified in the application for amendments, the decision on the application for amendments.

77. The authorized body (expert organization) of the reference state conducts the examination and draws up an expert opinion according to Annex No. 8 within 30 working days from the date of the decision to initiate the procedure for making changes to the registration dossier.

78. The conclusions contained in the expert report shall be unambiguous and understandable.

79. The grounds for preparation by the authorized body (expert organization) of the reference state of an expert opinion on impossibility to make changes in the registration dossier are:

a) unreliability of the submitted information justifying the introduction of changes (including those revealed in the course of implementation by the authorized bodies of state control (supervision) over the circulation of medical devices);

b) absence in the documents submitted by the applicant of information confirming that changes made to the documents contained in the registration dossier do not entail changes in the properties and characteristics of the medical device affecting its safety, quality and effectiveness, or improve the properties and characteristics with unchanged functional purpose and (or) principle of operation of the medical device;

c) the need to conduct a new registration of the medical device in accordance with paragraph 67 of these Rules.

80. The authorized body (expert organization) of the reference state within 10 working days from the date of registration (receipt) of the expert opinion on the impossibility of making changes in the registration dossier takes a decision to refuse to make these changes, draws up and issues to the applicant in the manner specified in the application for amendments, a notice of refusal to make changes in the registration dossier (with justification of the reasons for refusal and attaching a copy of the expert opinion of the authorized body (expert organization) of the reference state).

81. After registration in the reference State of the expert opinion on the possibility of making changes in the registration dossier, the authorized body (expert organization) of the reference State places in its information system the registration dossier containing the application for amendments and the expert opinion.

82. In case of absence of the state (states) of recognition the authorized body (expert organization) of the reference state within 10 working days from the date of execution of the expert opinion on the possibility of making changes in the registration dossier:

a) makes a decision on making changes to the registration dossier and places in the unified register of medical devices registered within the Union information on making changes to the registration dossier in accordance with the Procedure for the formation and maintenance of the information system, as well as scanned copies of the documents amended;

b) within 10 working days from the date of the decision to amend the registration dossier notifies the applicant in the manner specified in the application for amendments, as well as in the case of amendments to the registration certificate and (or) annex thereto, draws up and issues to the applicant in the manner specified in the application for amendments the re-issued registration certificate and annex thereto with the same number (indicating the date of the relevant amendments) and returns the previously issued registration certificate and annex thereto

83. In the case of the State(s) of recognition and provided that there are no disagreements between the authorized body (expert organization) of the reference State and the authorized body (expert organization) of the State(s) of recognition regarding the agreement of the expert opinion, the authorized body (expert organization) of the reference State:

a) within 10 working days from the date of receipt from the authorized bodies (expert organizations) of all states of recognition of confirmation of approval of the expert opinion or from the date of expiry of the term provided for in paragraph 50 of these Rules (provided that the applicant has submitted to the authorized body (expert organization) of the reference state a translation of the operating document or instructions for use of the medical device, service manual and the text of the label into the state languages of the states in the case of

b) within 10 working days from the date of the decision to amend the registration dossier notifies the applicant in the manner specified in the application for amendments, as well as in the case of amendments to the registration certificate and (or) annex thereto, draws up and issues to the applicant in the manner specified in the application for amendments the re-issued registration certificate and annex thereto with the same number (indicating the date of the relevant amendments) and returns the previously issued registration certificate and annex thereto

84. Non-approval of the expert opinion of the authorized body (expert organization) of the reference state in one of the states of recognition is a reason for exclusion of information about this state from the registration certificate.

85. If the authorized body (expert organization) of the recognition State has not agreed with the expert report and the authorized body (expert organization) of the reference State agrees with the conclusions of the authorized body (expert organization) of the recognition State as to the impossibility of amending the registration dossier, the authorized body (expert organization) of the reference State:

a) within 10 working days from the date of receipt from the authorized bodies (expert organizations) of all States of recognition of confirmation of approval (non-approval) of the expert report or from the date of expiration of the period provided for in paragraph 50 of this Regulation, takes a decision to refuse to amend the registration dossier;

b) within 10 working days from the date of the decision to refuse to amend the registration dossier shall execute and issue to the applicant in the manner specified in the application for amendments, a notice of refusal to amend the registration dossier (with justification of the reasons for refusal, as well as attaching a copy of the expert opinion of the authorized body (expert organization) of the reference state, copy (copies) of the confirmation of approval (non-approval) of the expert opinion and the original (duplicate) of the registration certificate).

86. If the authorized body (expert organization) of the recognition State has not agreed with the expert report and the authorized body (expert organization) of the reference State does not agree with the conclusions of the authorized body (expert organization) of the recognition State as to the impossibility of amending the registration dossier, the authorized body (expert organization) of the reference State:

a) within 10 working days from the date of receipt from the authorized bodies (expert organizations) of all states of recognition of confirmation of approval (non-approval) of the expert opinion or from the date of expiry of the term established for the provision by the states of recognition of the said confirmation (provided that the applicant has submitted to the authorized body (expert organization) of the reference state a translation of the operational document or instructions for use of the medical device, service manual and those

takes a decision to amend the registration dossier and to exclude from the registration certificate the information on the State (States) of recognition, the authorized body (expert organization) of which has not agreed the expert opinion;

posts in the unified register of medical devices registered within the Union information on changes made to the registration dossier in accordance with the Procedure of formation and maintenance of the information system, as well as scanned copies of documents in which changes have been made;

b) within 10 business days from the date of the decision to amend the registration dossier:

notifies the applicant on making amendments to the registration dossier and on exclusion from the registration certificate of information about the State (States) of recognition, the authorized body (expert organization) of which did not agree the expert opinion, in the manner specified in the application for amendments (with attachment of a copy of confirmation of non-agreement of the expert opinion);

draws up and issues to the applicant in the manner specified in the application for amendments the re-issued registration certificate and its annex, from which the information on the State(s) of recognition, the authorized body (expert organization) of which did not agree with the expert opinion, is excluded, and in which amendments are made in accordance with the application for amendments, with retention of the former number (with indication of the date of the relevant amendments);

returns to the applicant in the manner specified in the application for amendments the previously issued registration certificate and its annex with a note on their invalidity (with indication of the date).

VI. Procedure for amendments to the registration file on notice

87. The procedure for amendment of the registration file by notification applies in the following cases:

(a) Changes relate to the validity periods of the documents contained in the registration dossier (actualization of the documents in the registration dossier by the applicant);

b) changes are made by the manufacturer of medical devices of potential application risk class 1 or non-sterile medical devices of potential application risk class 2a, who has evaluated the quality management system of the medical device (including the processes of design and development of medical devices) in accordance with the Requirements for the quality management system;

c) the changes concern the following information about the manufacturer of the medical device or its authorized representative:

name of the legal entity (full and abbreviated (if any), including company name), location address or business address;

surname, name, patronymic (if any), address of residence of an individual entrepreneur or address of the place of business and details of the identity document;

d) changes in the name of the medical device in terms of trademark and other means of individualization;

e) changes consist in exclusion of information on the model (brand) of a medical device from the registration certificate.

88. In order to make changes in the registration dossier in the notification procedure the applicant sends the following documents and information to the authorized body (expert organization) of the reference state:

a) application for amendments to the registration dossier in a notification procedure (on paper and/or electronically) in the form according to Annex No. 9 (hereinafter in this section — application for amendments);

b) copy of the document confirming the powers of the manufacturer’s authorized representative (if there is an authorized representative of the manufacturer);

c) documents and information on the relevant changes, including documents confirming the changes and certifying that the introduction of these changes does not entail changes in the properties and characteristics of the medical device affecting its safety, quality and effectiveness, or improves its properties and characteristics while keeping the functional purpose and (or) principle of operation of the medical device unchanged;

d) reports on the results of primary, periodic (scheduled) and unscheduled inspection of production (in the case stipulated by subparagraph «b» of paragraph 87 of these Rules);

e) copies of documents confirming the payment for the procedure of making changes to the registration dossier in the notification procedure in the reference state, as well as issuance of the registration certificate in the reference state (if necessary);

f) the original of the registration certificate (duplicate) (in case of necessity to make changes in it);

g) inventory of documents.

89. The application for changes and documents confirming the changes (including reports on the results of production inspection) shall be placed by the authorized body (expert organization) of the reference State in its information system with access provided only to the authorized bodies (expert organizations) of the reference State and the State(s) of recognition.

90. The authorized body (expert organization) of the reference state within 7 working days from the date of receipt of the application for amendments, as well as documents and information specified in paragraph 88 of these Rules, shall verify the completeness and accuracy of the information contained therein (including the validity of reports on the results of inspection of production).

91. If an application for amendments is submitted in violation of the requirements of these Rules, contains unreliable information and (or) documents and information specified in paragraph 88 of these Rules are not submitted in full, the authorized body (expert organization) of the reference state within 7 working days from the date of receipt of such an application, documents and information shall notify the applicant on the need to eliminate the identified violations and (or) submission of missing documents within 30 working days from the date of placement of the relevant documents and information.

92. If after 30 working days the applicant has not eliminated the identified violations and (or) has not submitted missing documents, the authorized body (expert organization) of the reference state within 3 working days takes a decision to return the application for amendments and documents (with justification of the reasons for return).

93. Within 3 working days from the date of submission of the application for amendments, documents and information complying with the requirements of these Rules, as well as in case of elimination of the identified violations and (or) submission of documents complying with the requirements of these Rules within the period established by paragraph 91 of these Rules, the authorized body (expert organization) of the reference state makes a decision on the beginning of the procedure for making amendments to the registration dossier in a notification manner and places in its information system the register of

94. Where the report on the results of the production inspection has expired (for a case under paragraph 87(b) of this Regulation), the application for amendment shall not be accepted and the amendment of the registration file shall be carried out in accordance with the procedure provided for in Section V of this Regulation.

95. Introduction of changes in the registration dossier in the notification procedure is carried out by the authorized body (expert organization) of the reference state within 15 working days from the date of making a decision on the beginning of the procedure of introduction of changes in the registration dossier in the notification procedure.

96. The procedure for amendments to the registration file by notification does not require agreement with the recognizing States. Therefore, States of recognition are not indicated in the request for amendment.

97. If the changes are made to the information contained in the registration certificate, the authorized body of the reference state issues a new registration certificate with the same number (indicating the date of the relevant changes).

98. The grounds for adoption by the authorized body (expert organization) of the reference state of the decision to refuse to make changes in the registration dossier in the notification procedure are:

a) unreliability of the submitted information justifying the introduction of changes in the notification procedure (including expiration of the report on the results of production inspection);

b) non-compliance of the submitted documents and information with paragraph 88 of these Rules;

c) the need to conduct a new registration of the medical device in accordance with paragraph 67 of these Rules;

d) non-compliance of the introduced changes with the cases specified in paragraph 87 of this Regulation.

99. The authorized body (expert organization) of the reference state within 5 working days from the date of the decision to refuse to make changes to the registration dossier in the notification procedure shall execute and issue to the applicant in the manner specified in the application for amendments, a notice of refusal to make changes to the registration dossier in the notification procedure with the justification, as well as return to the applicant in the manner specified in the application for amendments, previously issued registration certificate (duplicate) and the annex thereto

100. The authorized body of the reference state within 5 working days from the date of the decision to amend the registration dossier in a notification procedure:

a) place in the unified register of medical devices registered within the Union, information on amendments to the registration dossier in accordance with the Procedure for the formation and maintenance of the information system, as well as scanned copies of documents that have been amended;

b) execute and issue to the applicant in the manner specified in the application for amendments, the notice of amendments to the registration dossier in the notification procedure, as well as, if necessary, the re-issued registration certificate and its annex with retaining the previous number (indicating the date of the relevant amendments);

c) return to the applicant in the manner specified in the application for amendments the previously issued registration certificate (duplicate) and its annex with a note on their invalidity (with indication of the date) in case of their submission.

VII. Procedure for issuing a duplicate registration certificate

101. In case of loss (damage) of the registration certificate the applicant has the right to apply to the authorized body of the reference state with an application for issuance of a duplicate registration certificate (on paper and (or) in electronic form) in the form according to Annex N 10.

102. In case of deterioration of the registration certificate, the application for issuance of a duplicate of the registration certificate shall be accompanied by the deteriorated registration certificate.

103. Within 5 working days from the date of receipt of the application for issuance of a duplicate of the registration certificate, the authorized body of the reference state shall issue a duplicate of the registration certificate on the form and shall issue it to the applicant in the manner specified in application for issuance of a duplicate of the registration certificate.

104. If the submitted application for issuance of a duplicate of the registration certificate is improperly executed and (or) it contains unreliable information, the authorized body of the reference state shall issue a decision on refusal to issue a duplicate of the registration certificate.

VIII. Procedure for approval of the expert report on a registered medical device

105. The procedure of registration of a medical device registered in accordance with these Rules in the Member States, not specified in the registration certificate, shall be carried out by approval of the expert opinion by the authorized bodies (expert organizations) of these Member States. Following the results of approval by the authorized body of the reference state, the registration certificate shall be issued with indication of all the states of recognition, the authorized bodies (expert organizations) of which have agreed the expert opinion.

106. The applicant shall submit the following documents (copies of documents) to the authorized body (expert organization) of the reference state:

a) registration dossier containing an application for approval of an expert opinion on a registered medical device (indicating the state(s) of recognition not specified in the registration certificate) (on paper and (or) in electronic form) in the form according to Annex No. 11 (hereinafter in this section — application for approval of an expert opinion) and documents according to the list in Annex No. 12;

b) copies of documents on payment for issuance of a new registration certificate in the referring state (if there are relevant requirements);

c) copies of documents on payment for the procedure of agreement of the expert opinion in the State (States) of recognition indicated in the application for agreement of the expert opinion.

107. The authorized body (expert organization) of the reference state within 7 working days from the date of receipt of the application for approval of the expert opinion and the documents specified in paragraph 106 of these Rules, shall verify the completeness and accuracy of the information contained in them.

108. If an application for approval of an expert opinion is submitted in violation of the requirements of these Rules, contains unreliable information and (or) the documents specified in paragraph 106 of these Rules are not submitted in full, the authorized body (expert organization) of the reference state within 7 working days from the date of receipt of such application and documents shall notify the applicant on the need to eliminate the identified violations and (or) submission of missing documents within 30 working days from the date of placement of the relevant documents.

109. If after 30 working days the applicant has not eliminated the identified violations and (or) has not submitted missing documents, the authorized body (expert organization) of the reference state within 3 working days takes a decision to return the application for approval of the expert opinion and documents (with justification of the reasons for return).

110. Within 3 working days from the date of submission of the application for approval of the expert opinion and documents complying with the requirements of these Rules, as well as in case of elimination of the identified violations and (or) submission of documents complying with the requirements of these Rules within the term established by paragraph 108 of these Rules, the authorized body (expert organization) of the reference state shall take a decision on conducting the procedure of approval of the expert opinion on the registered medical device and shall place in its information system the decision on the approval of the expert opinion on the registered medical device.

111. Approval of the expert opinion by the states of recognition specified in the application for approval of the expert opinion shall be carried out in accordance with paragraphs 46, 48 — 52 and 54 of these Rules.

112. Failure to approve the expert opinion in one of the States of recognition specified in the application for approval of the expert opinion shall be a ground for refusal to circulate the medical device in the territory of that State of recognition.

113. Within 10 working days from the day of receipt from all authorized bodies (expert organizations) of the states of recognition specified in the application for approval of the expert opinion, confirmation of approval (non-approval) of the expert opinion or from the day of expiry of the term established by paragraph 50 of these Rules, the authorized body (expert organization) of the reference state shall take a decision on issuance of the re-issued registration certificate (in case of existence of the states of recognition, the authorized bodies (expert organizations) of the reference state shall take a decision on issuance of the re-issued registration certificate).

Within 10 working days from the date of the decision to issue a reissued registration certificate, the authorized body (expert organization) of the reference state:

places in the unified register of medical devices registered within the Union information on the states of recognition specified in the application for approval of an expert opinion, the authorized bodies (expert organizations) of which have approved the expert opinion, as well as scanned copies of documents which have been amended, in accordance with the Procedure for the formation and maintenance of the information system;

draws up and issues to the applicant in the manner specified in the application for approval of the expert opinion, a re-issued registration certificate and its annex with retaining the previous number (indicating all states of recognition, authorized bodies (expert organizations) of which approved the expert opinion, and the date of the relevant changes);

returns to the applicant in the manner specified in the application for approval of the expert opinion, previously issued registration certificate (duplicate) and its annex with a note on their invalidity (with indication of the date);

shall issue to the applicant in the manner specified in the application for approval of the expert opinion a notice of refusal to register the medical device by the state of recognition specified in the application for approval of the expert opinion, accompanied by a copy of the confirmation of non-agreement of the expert opinion by the authorized body (expert organization) of the said state (if there is a state of recognition, the authorized body (expert organization) of which has not agreed the expert opinion).

Within 10 working days from the date of decision on refusal to issue a reissued registration certificate, the authorized body (expert organization) of the reference state:

shall return to the applicant in the manner specified in the application for approval of the expert opinion the previously issued registration certificate (duplicate) and its annex;

shall issue to the applicant in the manner specified in the application for approval of the expert opinion a notice of refusal to register the medical device by the state of recognition specified in the application for approval of the expert opinion, accompanied by a copy of the confirmation of non-approval of the expert opinion by the authorized body (expert organization) of the specified state, as well as the original (duplicate) of the registration certificate.

IX. Procedures for suspension or revocation (revocation) of the registration certificate

114. Suspension of the registration certificate shall be carried out by the authorized body of the reference state in the following cases:

a) based on the results of monitoring of safety, quality and effectiveness of medical devices during the post-registration period — when a potential serious threat to human health is identified;

b) based on the results of state control (supervision) over the circulation of medical devices — if there is information about facts and circumstances that pose a threat to the life and health of citizens and medical workers in the use and operation of medical devices;

c) absence in the registration dossier of up-to-date information on the authorized representative of the manufacturer (for manufacturers from third States).

115. The decision on suspension of the registration certificate (with indication of reasons, date and term of suspension) is made by the authorized body of the reference state in accordance with the legislation of this state.

116. The period of suspension of the registration certificate may not exceed 6 months, and the sale and use of such medical devices in the reference State and State(s) of recognition are not allowed.

117. The authorized body of the reference state within 5 working days from the date of the decision to suspend the registration certificate enters the relevant information in the unified register of medical devices registered within the Union and informs the authorized bodies of the recognition states and the Eurasian Economic Commission using the means of the integrated system, as well as the applicant by handing the notice personally against signature, or sending the notice by registered mail with the notice

118. The applicant within the period established by the authorized body of the reference state is obliged to eliminate the circumstances that led to the suspension of the registration certificate, and to notify in writing this authorized body (with the attachment of supporting documents). According to the results of consideration of the documents submitted by the applicant, the authorized body of the reference state makes a decision on renewal or cancellation (revocation) of the registration certificate (indicating the date of renewal or cancellation (revocation) of the registration certificate).

119. The authorized body of the reference state within 5 working days from the date of the decision on renewal of the registration certificate shall enter the relevant information in the unified register of medical devices registered within the Union and notify the applicant of the decision in person against signature, or send the notice by registered mail with return receipt requested, or transmit it electronically or in the form of an electronic document signed with an electronic signature.

120. The decision on renewal of the registration certificate shall be made in accordance with the legislation of the reference state and shall enter into force from the date of its adoption.

121. In case of failure to eliminate by the applicant within the established period of time the circumstances that led to the suspension of the registration certificate, the authorized body of the reference state within 3 working days from the date of expiration of the specified period shall take a decision to cancel (annul) the registration certificate (with justification).

122. The authorized body of the reference state shall immediately enter the relevant information in the unified register of medical devices registered within the Union and notify the applicant of the cancellation of the validity (revocation) of the registration certificate by handing the notice to the applicant personally against signature, or sending the notice by registered mail with return receipt requested, or sending it electronically or in the form of an electronic document signed with an electronic signature.

123. The grounds for the authorized body of the reference state to take a decision on cancellation (revocation) of the registration certificate or cancellation of registration of a medical device (models (brands) of a medical device, information about which is provided in the registration certificate) are:

a) submission by the manufacturer of an application for cancellation (revocation) of the registration certificate (on paper and (or) electronically) in the form according to Annex No. 13;

b) identification of cases of submission by the applicant of unreliable information that could not have been established during the registration of a medical device (including during the implementation by the authorized bodies of state control (supervision) over the circulation of medical devices);

c) an effective decision of the court of the Member State on cancellation (revocation) of the registration certificate or on cancellation of registration of the medical device (models (brands) of the medical device, information about which is provided in the registration certificate);

d) submission by the authorized body based on the results of state control (supervision) over the circulation of medical devices of information on facts and circumstances that pose a threat to the life and health of citizens and medical workers in the application and operation of a medical device;

e) loss by a medical product of the status of a medical product in connection with the introduction of amendments to acts falling within the Union’s right or on the basis of the decision of the Advisory Committee on the results of work on the settlement of disagreements on the issues of attribution of products to medical products.

124. An application for cancellation (revocation) of a registration certificate may be submitted by an authorized representative of the manufacturer if the following conditions are simultaneously met:

a) availability in the registration dossier of an up-to-date document confirming the authorization of the manufacturer’s authorized representative, or submission of such document to the authorized body of the reference state together with the application for cancellation (revocation) of the registration certificate;

b) submission to the authorized body of the reference state together with the application for cancellation (revocation) of the registration certificate of the duly certified document of the manufacturer confirming its intention to cancel the registration certificate (revoke it).

125. If the application for cancellation (revocation) of the registration certificate is submitted in violation of the requirements of these Rules, the documents are submitted incomplete or contain unreliable information, the authorized body of the reference state within 7 working days from the date of receipt of such application and documents shall make a decision to return them (specifying the reasons for return).

126. The authorized body of the reference state within 7 working days from the date of occurrence of one of the grounds specified in paragraph 123 of these Rules shall make a decision on cancellation of validity (revocation) of the registration certificate or on cancellation of registration of the medical device (models (brands) of the medical device, information about which is provided in the registration certificate).

127. The authorized body of the reference state shall, within 5 working days from the date of making a decision on cancellation of validity (revocation) of the registration certificate or on cancellation of registration of a medical device (models (brands) of a medical device, information about which is provided in the registration certificate):

a) shall place in the unified register of medical devices registered within the Union information on cancellation (revocation) of the registration certificate or on cancellation of registration of a medical device (models (brands) of a medical device, information about which is provided in the registration certificate);

b) shall notify the applicant of the cancellation (revocation) of the registration certificate by delivering the notice personally against signature, or sending it by registered mail with return receipt requested, or sending it electronically or in the form of an electronic document signed with an electronic signature;

c) notify the applicant on cancellation of registration of medical devices (models (brands) of medical device, information about which is presented in the registration certificate) and on necessity to make changes in the registration dossier in terms of exclusion of these medical devices (models (brands) of medical device) by handing the notice personally against signature, or sending it by registered mail with return receipt requested, or sending it electronically or in the form of an electronic document signed by electronic signature.

Annex N 1

to the Rules for Registration and Examination

safety, quality and efficiency

medical devices

REGISTRATION CERTIFICATE FORM MEDICAL

DEVICE AND RULES FOR ITS COMPLETION

I. Form of the registration certificate medical device

                Emblem of the Eurasian Economic Union (1)

                      EURASIAN ECONOMIC UNION (2)

_______________________________________________________________________

     (name of the authorized body of the reference state) (3)

            MEDICAL DEVICE REGISTRATION CERTIFICATE (4)

                     MI-XY-Z dated «__» ________ 20__.                   (5)

    According to __________________________________________________ (6)

                       (number and date of the order of the authorized body

                           of the reference state on registration

                                    medical device)

this registration certificate for a medical device

выдано: _______________________________________________________________ (7)

              (name of the manufacturer, its location)

_______________________________________________________________________ (8)

(name of the production site (including its actual address)

        or a reference to an annex if two or more are indicated

                      production sites)

_______________________________________________________________________ (9)

      (name of the manufacturer’s authorized representative

 in the territories of the member states of the Eurasian Economic Union,

                     including its location)

is that ___________________________________________________________ (10)

                      (name of medical device)

potential risk class of the medical device: _________ (11)

registered and authorized for issuance in the following territories

Member States of the Eurasian Economic Union

______________________________________________________________________ (12)

           (names of the reference State and the State)

                          (States) of recognition)

Medical device models (brands), their composition, accessories and

production sites are given in the annex (if any) to this report

registration certificate of medical device on __ pages (13)

The Annex is an integral part of this Registration Statement

of the medical device’s credentials.

Term of validity of the registration certificate of a medical device:

indefinitely (14)

Date of registration of the medical device: «__» _______ 20__.            (15)

Number and date of the order of the authorized body of the reference state on

amendments to the registration certificate of a medical device:

«__» _______ 20__ г. N (16)

__________________________________________________________

(full name of the head (authorized person) of the authorized body)

________________________ M.P. (17)

(signature)

N _____ (18)

ANNEX TO THE REGISTRATION CERTIFICATE OF A MEDICAL DEVICE	(1)
MI-XY-Z dated «__» _________ 20__.	(2)

N n/a	Name
1.	Model (brand) of medical device (if available)
2.	Composition
3.	Accessories (if available)
	(3)

N n/a	Names and actual addresses of production sites
1.	…
…	…
	(4)

(full name of the head (authorized person) of the authorized body)

		M.P.	(5)
(signature)
			Sheet __ (6)
			N _____ (7)

II. Rules for filling in the registration certificate medical device

1. Registration certificate of a medical device (hereinafter — registration certificate) shall be filled in by the authorized body of the reference state in the Russian language using electronic printing devices and, if there is a corresponding requirement in the legislation of the reference state — in the state language of this state.

2. Filling in of the registration certificate in Russian and the state language of the reference state shall be carried out on different sides of the registration certificate.

3. The registration certificate shall be a document of strict accountability and shall be printed on a letterhead, which shall be produced by printing method and shall have degrees of protection in accordance with the legislation of the reference state.

If necessary, the name of the manufacturer, its location (address of a legal entity, place of residence of an individual registered as an individual entrepreneur) and information about the product (model, brand, article, etc.) may be indicated using letters of the Latin alphabet.

4. The names of the manufacturer, authorized representative of the manufacturer and production sites shall be indicated in the registration certificate in the following sequence:

a) for residents of member states of the Eurasian Economic Union (hereinafter respectively — member states, the Union):

legal form;

full name (for legal entities it shall be indicated in quotation marks);

abbreviated name (in brackets) (if any);

the name of the state;

b) for non-residents of Member States:

full name;

legal form;

abbreviated name (in brackets) (if any);

name of the state (in Russian and (or) in the state language of the reference state).

The requisites are separated by commas.

5. The indication of the address in the registration certificate shall be made in the following sequence:

street name (indicating the element of the street and road network of urban infrastructure), house number, room number (if any);

name of the settlement (indicating type);

name of neighborhood;

name of the region (oblast, krai) (with indication of type);

zip code;

P.O. Box number (if available);

the name of the state.

For non-residents of Member States, the address shall be indicated using the letters of the Latin alphabet.

The requisites are separated by commas.

6. Information about the manufacturer and the manufacturer’s authorized representative specified in the registration certificate, operating document or instructions for use of the medical device, service manual, as well as in the text of the medical device marking shall be identical and correspond to the information specified in the document or information confirming the registration of the manufacturer and authorized representative as a legal entity or individual entrepreneur.

7. All fields of the registration certificate must be filled in (the original registration certificate does not have numbered fields).

8. The registration certificate shall specify:

(a) in field 1, the emblem of the Union;

b) in field 2 — an inscription made in 1 line:

«EURASIAN ECONOMIC UNION»;

c) in field 3 — full name of the authorized body of the reference state;

d) in field 4 — an inscription made in 1 line:

«MEDICAL DEVICE REGISTRATION STATEMENT»;

e) in field 5 — number of registration certificate and date of its issue.

The number of the registration certificate shall be formed in the following order:
MИ — XY — Z

___________ ,
1 23 4

Where:

element 1 — medical device;

element 2 — 2-digit alphabetic code of the reference state in accordance with international standard ISO 3166-1;

element 3 — 2-digit alphabetic code of the states of recognition in accordance with the international standard ISO 3166-1 (codes of the states of recognition that confirmed the agreement of the expert report shall be indicated);

element 4 — 6-digit serial number of the registration certificate assigned by the authorized body of the reference state (assigned automatically from the unified register of medical devices registered within the Union, the procedure for the formation and maintenance of which is approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 30, and remains unchanged during circulation of the medical device within the Union);

f) field 6 — number and date of the order of the authorized body of the reference state on registration of the medical device;

g) in field 7 — full name and location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for an individual registered as an individual entrepreneur;

h) in field 8 — names and actual addresses of the production sites performing the entire process of manufacturing of the medical device or certain stages thereof. If there are two or more production sites, it is allowed to indicate information about them in the annex to the registration certificate;

i) in field 9 — full name of the manufacturer’s authorized representative on the territory of the Member States, its location (address of a legal entity) — for a legal entity or surname, name, patronymic (if any), place of residence — for a natural person registered as an individual entrepreneur. In case of absence of the authorized representative of the manufacturer on the territory of the Member State (in case the manufacturer is a resident of the Member States), a dash shall be placed in this field;

j) field 10 — full name of the medical device, including trademark and other means of individualization (if any), which shall correspond to the name specified in the expert report;

k) field 11 — class of potential risk of medical device application, confirmed during medical device examination;

(m) In field 12, the names of the reference State and the State(s) of recognition (separated by commas);

n) in field 13 — number of sheets of the annex to the registration certificate (to be filled in if there is an annex);

o) in field 14 — the words «Validity period of the registration certificate of the medical device: indefinitely» shall be indicated;

n) field 15 — date of registration of the medical device, which shall be indicated in a word-numeric manner: number — two Arabic numerals (in quotes), month — word, year — four Arabic numerals (with the abbreviation of the year «y.»);

p) in field 16 — the date of the last amendment of the registration certificate, which shall be indicated in a verbal and numeric manner: number — two Arabic numerals (in quotes), month — in words, year — in four Arabic numerals (with the abbreviation of the year «y.»). This field shall be filled in when making changes in the registration dossier with the issuance of a new registration certificate with the previous number and indicating the number of the corresponding order on making changes;

c) in field 17 — position, signature, surname, name, patronymic (if any) of the head (authorized person) of the authorized body that issued the registration certificate, certified by the seal of this authorized body (if any). The use of facsimile instead of signature is not allowed;

t) in field 18 — typographical number, series and serial number of the blank registration certificate, inserted at the time of its production.

9. If there is information on models (brands) of a medical device, their composition and accessories or two or more production sites, an annex to the registration certificate shall be filled in, which is an integral part of the registration certificate. Each sheet of the annex shall be numbered. The annex to the registration certificate shall specify:

a) in field 1 — inscription made in 2 lines:

«ANNEX TO THE REGISTRATION CERTIFICATE MEDICAL DEVICE.»

b) in field 2 — number of registration certificate;

c) in field 3 — models (brands) of the medical device, their composition and accessories (if any);

d) in field 4 — names and actual addresses of production sites performing the whole process of production of a medical device or its certain stages (if it is necessary to indicate information on two or more production sites);

e) in field 5 — position, signature, surname, name, patronymic (if any) of the head (authorized person) of the authorized body that issued the registration certificate, certified by the seal of the authorized body (if any). The use of facsimile instead of signature is not allowed;

(e) Field 6 shall indicate the sheet number of the annex;

g) in field 7, the typographical number affixed at the time of production of the annex form.

10. When filling in the registration certificate and (or) an annex thereto, indication of information not provided for by these Rules, as well as the use of abbreviations of words (except commonly used) and correction of the text shall not be allowed.

11. In case of loss or damage of the registration certificate, the authorized body of the reference state shall issue a duplicate of this registration certificate. In this case in the upper right corner of the registration certificate the following marks shall be put: «Duplicate issued «__» ______ 20__» and «The original registration certificate of the medical device is recognized as invalid».

Annex N 2

to the Rules for Registration and Examination

safety, quality and efficiency

medical devices

FORM OF APPLICATION FOR EXPERT EXAMINATION OF A MEDICAL DEVICE

To the authorized body

(expert organization) of a member state of the

Eurasian Economic Union

___________________________

(name of the reference State)

___________________________

(name of the State(s) of recognition)

APPLICATION

on expert examination of a medical device

______________________________________________________________________

(full and abbreviated (if any), including company name of the person on whose behalf the registration is made (manufacturer (authorized representative of the manufacturer), legal form of the legal entity)

hereby requests an examination of the medical device:

1.	Name of medical device
2.	Purpose of medical device
3.	A medical device for in vitro diagnostics?	Yes No
4.	Field of application of a medical device (in accordance with the classifier of fields of medical application of medical devices, approved by Decision of the Board of the Eurasian Economic Commission of April 16, 2019 N 62)
5.	Potential risk class of the medical device
6.	Should a manufacturing inspection be conducted (to be specified if the medical device to be registered is a medical device of potential risk class 1 or a non-sterile medical device of potential risk class 2a and an initial manufacturing inspection has not previously been conducted)?	Yes No
7.	Code of the type of medical device (according to the nomenclature of medical devices of the Eurasian Economic Union, the rules for maintaining which are approved by Decision of the Board of the Eurasian Economic Commission of December 29, 2015 N 177)
8.	Does the medical device contain a drug product?	Yes No
9.	Model (brand) of the medical device, its composition and accessories

N	Name	Manufacturer	Country
1.	Model (brand) of medical device (if available)
2.	Composition (if any)
3.	Accessories (if available)

10.	Manufacturer information

organizational and legal form, full name and abbreviated name (if any), country, (full name of individual entrepreneur)

number, date registration

location (address of a legal entity, address of residence of an individual entrepreneur)

actual address

phone and fax numbers, e-mail address (if available)

Full name and position of the manager, full name and position of the contact person

11.	Information about the production site(s)

N	legal form, full name and abbreviated name (if any), (full name of individual entrepreneur), (full name of individual entrepreneur)	number, date and validity of the authorization document (if any)	actual address	telephone and fax numbers, e-mail address (if available)	Full name and position of the manager, full name and position of the contact person
1.
…

12.	Information on the manufacturer’s authorized representative (if any)

legal form, full name and abbreviated name (if any), country, (full name of individual entrepreneur)

registration number, date of registration

location (address of a legal entity, address of residence of an individual entrepreneur)

actual address

Telephone and fax numbers, e-mail address (if available)

Full name and position of the manager, full name and position of the contact person

13.	Information on the document confirming payment for the medical device registration procedures
14.	Method of receiving notifications (decisions) from the authorized body (expert organization) of the reference state:

	personally signed
	by registered mail with return receipt requested
	electronically via telecommunication channels (when selecting this method, it is necessary to specify the e-mail address(es) to which notifications should be sent)
	in the form of an electronic document signed with an electronic signature

15.	Method of obtaining a registration certificate for a medical device and its annexes:

	in person
	on paper by registered mail with return receipt requested

I guarantee the truthfulness and identity of the information contained in the registration dossier and application form
Date of application
Full name and position of the head of the manufacturer (authorized representative of the manufacturer)
Signature, stamp of the manufacturer (authorized representative of the manufacturer)

Annex N 4

to the Rules for Registration and Examination

safety, quality and efficiency

medical devices

LIST

DOCUMENTS REQUIRED FOR REGISTRATION OF A MEDICAL DEVICE

Medical device of potential risk class of use

N n/a	Name of the document	1	2а	2б	3	Medical device of potential risk class of use	Note
1.	Statement	+	+	+	+	+	according to the forms provided for in Annexes N 2 and 3 to the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 46
2.	Power of attorney from the manufacturer for the right to represent interests during registration (if necessary)	+	+	+	+	+	is certified in accordance with international standards of certification or standards of certification established by the legislation of the reference state
3.	Contract of the manufacturer with the authorized representative of the manufacturer or its copy (if there is an authorized representative of the manufacturer). If the manufacturer’s authorized representative is not a resident of the reference state, encloses a copy of the document confirming registration of the manufacturer’s authorized representative as a legal entity or individual entrepreneur.	+	+	+	+	+	the copy shall be certified in accordance with international standards of certification or the standards of certification established by the legislation of the reference state
4.	Copy of the authorization document for the right of production in the producer’s country with attachment (if available)	+	+	+	+	+	is certified in accordance with international standards of certification or standards of certification established by the legislation of the reference state
5.	Copy of the document or information confirming the registration of the manufacturer as a legal entity or individual entrepreneur	+	+	+	+	+	the copy of the document shall be certified in accordance with international standards of certification or standards of certification established by the legislation of the reference state;the information is certified by the manufacturer
6.	Copy of the certificate of conformity of the quality management system to the requirements of ISO 13485 or the relevant regional or national (state) standard of a member state of the Eurasian Economic Union (hereinafter respectively — Member State, Union), issued in the name of the manufacturer of medical devices (production site) (if available)	+	+	+	+	+	is certified in accordance with international standards of certification or standards of certification established by the legislation of the reference state
7.	Declaration of conformity of the medical device to the mandatory requirements of non-member states (e.g. European Union directives or regulations) or an equivalent document (if available) or a copy of such documents	+	+	+	+	+	the copy is certified by the manufacturer (authorized representative of the manufacturer)
8.	Copy of the medical device registration certificate (free sale certificate, export certificate (except for medical devices manufactured for the first time in the territory of the Member State)) issued in the country of manufacturer (if available)	+	+	+	+	+	is certified in accordance with international standards of certification or standards of certification established by the legislation of the reference state
9.	Information on registration in other countries with reference to valid sources of such information and an electronic file containing such information or a copy of the document certifying the registration of the medical device in other countries (if available).	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
10.	Data on marking and packaging (full-color (with indication of color coding) layouts of packages and labels), marking text in Russian and state languages of the Member States (if necessary). The text of marking in the state languages of the Member States may be submitted after the formation of a positive expert opinion	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
11.	Information on development and production: process flow diagrams, main production stages, packaging, testing and final product release procedure	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
12.	Information about the manufacturer: name, type of activity, legal address, form of ownership, management structure, list of subdivisions and subsidiaries involved in the production of the medical device applied for registration, indicating their status and authorization	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
13.	Marketing information (history if product has been on the market for more than 2 years) (if available)	—	—	+	+	+(except grades 1 and 2a)	certified by the manufacturer (authorized representative of the manufacturer)
14.	Accident and recall reports (information is not provided for newly designed and engineered medical devices): a list of adverse events (incidents) or accidents related to the use of the product and an indication of the time period during which these events occurred. If there are too many adverse events (incidents), summaries of each type of event should be provided and the total number of events of each type reported should be indicated A list of medical device market recalls and/or explanatory notices and a description of the approach to addressing and resolving these issues by manufacturers in each of these cases. A description of the analysis and/or corrective actions taken in response to these cases	+	+	+	+	+(except Class 1)	certified by the manufacturer (authorized representative of the manufacturer)
15.	List of standards used by the manufacturer in the design and manufacture of the medical device (with the name and designation of the standards)	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
16.	Information on compliance of a medical device with the General requirements for safety and effectiveness of medical devices, requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 27 (hereinafter — the General Requirements), with the attachment of documents referenced in specified information	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
17.	A document establishing requirements to the technical characteristics of a medical device	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
18.	Protocols of technical tests conducted to prove compliance of the medical device with the General Requirements, test programs or copies of the said documents and (or) documents containing first party evidence	+	+	+	+	+(excluding reagents, reagent kits, control materials, calibrators, washing solutions and nutrient media)	copies of protocols shall be certified by the testing laboratory (center) or in accordance with the standards of certification established by the legislation of the reference state; copies of programs shall be certified by the testing laboratory (center) or by the manufacturer (authorized representative of the manufacturer);documents containing first party evidence shall be certified by the producer
19.	Biologic Evaluation Report for a medical device (if applicable)	+	+	+	+	—	certified by the manufacturer (authorized representative of the manufacturer)
20.	Protocols of studies (tests) to assess the biological effect of a medical device conducted to prove compliance of a medical device with the General requirements (if necessary), programs of studies (tests) or copies of the above documents	+	+	+	+	—	copies of protocols and programs shall be certified by the testing laboratory (center) or in accordance with the standards of certification established by the legislation of the reference state
21.	A report on clinical evidence of efficacy and safety of a medical device or a copy thereof	+	+	+	+	+(except Class 1)	copy of the report shall be certified by the manufacturer (authorized representative of the manufacturer)
22.	Report on clinical trial (research) of a medical device or report on clinical and laboratory trial (research) of a medical device for in vitro diagnostics (or its copy)	—	—	+	+	+	a copy of the report is certified by the medical organization or in accordance with the standards of certification established by the legislation of the reference state
23.	Risk analysis and management report or a copy thereof	+	+	+	+	+	copy of the report shall be certified by the manufacturer (authorized representative of the manufacturer)
24.	Data on medicinal products in the medical device (composition of the medicinal product, quantity, data on compatibility of the medicinal product with the medical device, registration of the medicinal product in the country of manufacturer)	+	+	+	+	—	certified by the manufacturer (authorized representative of the manufacturer)
25.	Biological safety data (if available)	+	+	+	+	—	certified by the manufacturer (authorized representative of the manufacturer)
26.	Data on the sterilization procedure, including information on process validation, results of testing for microbial content (bioburden), pyrogenicity, sterility (if applicable) and test methods, and data on package validation (for sterile articles).	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
27.	Information on special software (if any): manufacturer’s information on software validation	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
28.	Report on stability studies or its copy (in case of submission of the report in a foreign language with translation into Russian of the results and conclusions of the studies) — for products with shelf life	+	+	+	+	+	copy of the report shall be certified by the manufacturer (authorized representative of the manufacturer), the original shall be signed by the manufacturer
29.	Operational document or instructions for use of the medical device in Russian and in the official languages of the Member States (if necessary). An operational document or instructions for use of the medical device in the state languages of the Member States may be submitted after a positive expert opinion has been formed	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
30.	Service Manual — in case of absence of data in the operating documentation (if available).This document in the official languages of the recognizing States may be submitted after a positive expert opinion has been formed	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
31.	Report on the results of inspection of medical device production or its copy (if available)	+	+	+	+	+	copy of the report shall be certified by the inspection organization or the manufacturer (authorized representative of the manufacturer)
32.	A plan for collecting and analyzing data on the safety and effectiveness of medical devices at post-marketing stage	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
33.	Documents confirming the results of tests of medical devices for the purpose of type approval of measuring instruments (in respect of medical devices included in the list of types of medical devices to be attributed during their registration to measuring instruments, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 42), or copies thereof	+	+	+	+	+	copies of documents shall be certified by an organization authorized (notified) in accordance with the legislation of the Member State to perform tests on measuring instruments, or in accordance with the norms of certification established by the legislation of the reference state
34.	Photographic images of the general appearance of the medical device and accessories (if available) (size at least 180 mm x 240 mm)	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)
35.	Documents confirming the quality of a medicinal product, biological material and other substances that are part of a medical device and come into contact with the human body in accordance with the intended use of the medical product, as well as are intended for use only with regard to the intended use of the medical device defined by the manufacturer, and issued in accordance with the legislation of the country of origin of the medicinal product, biological material and other substances, or copies thereof (as applicable)	+	+	+	+	—	copies of documents shall be certified by the manufacturer (authorized representative of the manufacturer)
36.	Other documents provided by the applicant	+	+	+	+	+	copies of documents shall be certified by the manufacturer (authorized representative of the manufacturer)
37.	Inventory (if the registration dossier is submitted in paper form)	+	+	+	+	+	certified by the manufacturer (authorized representative of the manufacturer)

Annex N 5

to the Rules for Registration and Examination

safety, quality and efficiencymedical devices

EXPERT OPINION

ON THE EVALUATION OF SAFETY, QUALITY AND EFFECTIVENESS

MEDICAL DEVICE

__________________________________________________________________

(name of the authorized body (expert organization) of the reference state)

APPROVED

_________________________

(full name of the head of the authorized body

(expert organization), signature, seal)

«__» ____________ 20__ г.

EXPERT OPINION

on the evaluation of safety, quality and effectiveness

medical device

N _____ dated «__» ______ 20__.

1. general information about the medical device:

a) number and date of registration of applications for expert examination of a medical device and for registration of a medical device;

b) the name of the medical device;

c) medical device manufacturer, country;

d) production site(s), country;

e) authorized representative of the manufacturer (if any);

(e) Field of application and purpose;

g) type of medical device in accordance with the nomenclature of medical devices of the Eurasian Economic Union, the rules for maintaining which are approved by Decision of the Board of the Eurasian Economic Commission dated December 29, 2015 N 177;

h) the potential risk class of the medical device;

i) the composition of the medical device (model (brand) of the medical device (if any)) and its accessories (if any);

j) main technical characteristics of the medical device (model (brand, type) of the medical device (if any)).

2. Results of the examination of safety, quality and efficacy of the medical device (by applicability):

(a) Assessment of the correctness of categorizing the article as a medical device;

b) assessment of compliance with the class of potential risk of use of a medical device specified by the applicant in accordance with the Rules of classification of medical devices depending on the potential risk of use, approved by the Decision of the Board of the Eurasian Economic Commission of December 22, 2015 N 173;

c) assessment of the correctness of attributing a medical device (models (brands) of a medical device) to a certain type of medical devices in accordance with the nomenclature of medical devices of the Eurasian Economic Union, the rules for maintaining which are approved by the Decision of the Board of the Eurasian Economic Commission dated December 29, 2015 N 177;

d) assessment of compliance of models (brands) of a medical device (if any) included in one registration certificate with the criteria established by paragraph 19 of the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 46;

e) analysis and evaluation of evidentiary documents (materials) confirming compliance of a medical device with the General Requirements for Safety and Effectiveness of Medical Devices, requirements for their labeling and operational documentation for them, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 27 (hereinafter — the General Requirements):

analysis of the information submitted by the manufacturer on compliance of the medical device with the General Requirements, including analysis of correct identification of the provisions of the General Requirements applicable to the medical device;

assessment of compliance of technical test protocols issued by authorized organizations with the Rules of technical testing of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 28;

assessment of compliance of the protocols of research (testing) to assess the biological effect of medical devices, issued by authorized organizations, to the Rules for conducting research (testing) to assess the biological effect of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission of May 16, 2016. N 38;

analysis of the report on assessment of biological effect of a medical device (conducted, among other things, to confirm that materials coming into contact (interacting) with human tissues are identified (brands of materials and their manufacturers are specified), as well as to confirm the validity of the absence of the need to conduct studies (tests) to assess the biological effect);

analysis of the report on clinical evidence of efficacy and safety of the medical device (conducted to confirm the validity of the choice of methods for proving clinical efficacy and safety of the medical device, validity of the data used to prove clinical efficacy and safety of the medical device, as well as the validity of the conclusion on clinical efficacy and safety for all declared indications for use, taking into account the presence or absence of contraindications);

assessment of compliance of reports on clinical (clinical and laboratory) tests (studies) of medical devices with the Rules of clinical and clinical and laboratory tests (studies) of medical devices, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 29;

validity analysis of first party evidence (if any) to confirm compliance of the medical device with the General Requirements taking into account the class of potential risk of use of the medical device (for medical devices of classes of potential risk of use 2b and 3, the first party evidence must be accompanied by a test (research) program and justification of the selected methods);

analyzing the standards used by the manufacturer in the design and manufacture of the medical device;

analysis of safety and efficacy of the medicinal product as part of a medical device, its effect on the functionality of the medical device, compatibility of the medicinal product with the medical device (except for medical devices for in vitro diagnostics). The medicinal product must be registered and authorized for use in the state producing the medicinal product;

analysis of data on biological safety of a medical device based on the analysis of all materials of animal or human origin included in the medical device, as well as information on source (donor) selection, material selection, processing, storage, testing, validation of testing procedures, as well as handling of tissues, cells, substances of animal or human origin, cultures of microorganisms and viruses;

Analysis of the procedure and methods of sterilization of a medical device, materials justifying the method of sterilization, proposed methods of quality control and determination of sterilizing agent residues when using the chemical method of sterilization;

study of software validity based on the analysis of data on its verification and validation, including information on its development, measures and means of protection against unauthorized access and cybersecurity, testing by the manufacturer, identification and marking data;

analyzing the report on the stability of the medical device, validity of the declared shelf life;

review of the risk analysis report in order to confirm the completeness of the hazards, hazardous situations and related risks identified in such report, which can be assessed as unacceptable, as well as to confirm the manufacturer’s conclusion that there are no unacceptable risks or the acceptability of risks that are assessed as acceptable in the risk analysis report based on the analysis of the risk-benefit ratio;

confirmation on the basis of the submitted evidence (documents) of the validity of the manufacturer’s assessment result on compliance of the medical device with the General Requirements;

assessment of compliance of the operating document or instructions for use, service manual with the General Requirements;

assessment of compliance of medical device labeling with the General Requirements;

analyzing the requirements to the technical characteristics of a medical device;

evaluation of documents confirming the results of tests of medical devices for the purpose of type approval of measuring instruments (in respect of medical devices included in the list of types of medical devices to be classified as measuring instruments during their registration, approved by the Decision of the Council of the Eurasian Economic Commission dated February 12, 2016. N 42);

f) analysis of reports on the results of inspection of the production of a medical device (conducted in order to confirm the compliance of the declared medical device to the group (subgroup) of medical devices, taking into account the class of potential risk of use according to Annex N 2 to the Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices depending on the potential risk of their use, approved by the Decision of the Council of the Eurasian Economic Commission of November 10, 2017. N 106, as well as confirmation of the reliability of information on the production sites specified in the applications for registration and examination, which are covered by the report on the results of inspection of the production of medical devices);

g) analysis of data on quality management system certification (if any), including requirements for compliance with which the manufacturer’s quality management system is certified, and information on certificates (number, date of issue, certificate validity period, name and information on accreditation of the certification body);

h) confirmation of the validity of the indication of the production sites of the medical device to be registered;

(i) Analysis of data on the development and production of the medical device (flow diagrams of the manufacturing processes, key stages of production, packaging, testing and final product release procedures);

j) analyzing the marketing information provided by the manufacturer;

k) analysis of information submitted by the manufacturer on the presence or absence of reports on adverse events and (or) accidents related to the use of the medical device, recalls of the medical device from the market, notifications on the safety of the medical device, approaches to solving such problems by the manufacturer when they occur, description of corrective actions taken, as well as analysis of the ratio of the level of sales, number of accidents and recalls of the medical device from circulation;

(m) Analyzing the plan for collecting data on the safety and efficacy of the medical device at the post-marketing stage.

3. general conclusion on confirmation (non-confirmation) of safety, quality and efficacy of the medical device, recommendation on possibility (impossibility) of registration of the medical device.

He is warned about the responsibility for the reliability of the information stated in the expert report on the assessment of safety, quality and efficacy of the medical device.

_________________________________________________________ ______________________

(full name of the expert, position, academic degree (title) (if any)) (signature)

Annex N 6

to the Rules for Registration and Examination

safety, quality and efficiencymedical devices

CONCLUSION

ON CONFIRMATION OF APPROVAL (NON-APPROVAL) OF THE EXPERT REPORT

CONCLUSIONS ON THE RESULTS OF SAFETY, QUALITY

AND EFFECTIVENESS OF A MEMBER STATE’S MEDICAL DEVICE

OF THE EURASIAN ECONOMIC UNION, WHICH IMPLEMENTS

MEDICAL DEVICE REGISTRATION

______________________________________________________________________

(name of the authorized body (expert

(organization) States of recognition)

APPROVED

_______________________________________

(full name of the head of the authorized body

(expert organization), signature, seal)

«__» __________ 20__ г.

CONCLUSION

on confirmation of approval (non-approval) of the expert report

the conclusion of a member state of the Eurasian Economic

of the Union that carries out the registration of the medical device,

based on the results of safety, quality

and effectiveness of a medical device

N ______ dated «__» ___________ 20__.

1. Name of the authorized body (expert organization) of the Eurasian Economic Union member state that carries out registration of the medical device (hereinafter referred to as the reference state).

2. Date of placement of the expert report in the information system of the authorized body (expert organization) of the reference state.

3. the number of the expert report.

4. Name of the medical device (indicating the model (brand) of the medical device, its composition and accessories).

5. Manufacturer of the medical device (full and abbreviated name, legal form of the legal entity, location (address of the legal entity, place of residence of the individual registered as an individual entrepreneur)).

6. Production sites (full and abbreviated names, legal form of the legal entity, actual address).

7. Authorized representative of the manufacturer (full and abbreviated name, legal form of the legal entity, location (address of the legal entity, place of residence of the individual registered as an individual entrepreneur)) (if any).

8. Applicant.

9. Analysis of the expert opinion submitted by the authorized body (expert organization) of the reference state on the results of expert examination of safety, quality and efficacy of the medical device, as well as compliance of the documents of the registration dossier with the established requirements.

10. Confirmation of the correctness of translation of the operating document or instructions for use of the medical device, service manual, medical device labeling text into the state language in accordance with the requirements of the legislation of the Eurasian Economic Union member state (if applicable).

11. Results of the expert examination (conclusions on individual aspects of the expert report shall be indicated).

12. Conclusion (the general conclusion shall be indicated, in case of disagreement of the expert opinion — with justification of reasons).

13. Information on experts (full name, academic degree (title) (if any), place of work and position).

He was warned about the responsibility for the reliability of the information stated in the conclusion on confirmation of approval (non-approval) of the expert opinion of the reference state on the results of the examination of safety, quality and efficacy of a medical device.

_______________________________________________________ _______________________

(Name of the expert) (signature)

Annex N 7

to the Rules for Registration and Examination

safety, quality and efficiencymedical devices

APPLICATION FORM

ON AMENDMENTS TO THE REGISTRATION DOSSIER

MEDICAL DEVICE

To the authorized body

of a member state of the Eurasian Economic

Union

__________________________

(name of the reference State)

__________________________

(name of the State(s) of recognition)

APPLICATION

on amendments to the registration dossier

medical device

_________________________________________________________________________________________

(full and abbreviated (if any), including company name of the person on whose behalf the changes are made (manufacturer (authorized representative of the manufacturer), legal form of the legal entity)

hereby requests amendments to the registration dossier of the medical device

1. Name of medical device
2. Manufacturer of the medical device (full and abbreviated name, organizational and legal form of the legal entity, location (address of the legal entity, place of residence of the individual registered as an individual entrepreneur)
3. Production sites (full name, address)
4. Authorized representative of the manufacturer (if any) (full and abbreviated name, legal form of the legal entity, location (address of the legal entity, place of residence of the individual registered as an individual entrepreneur)
5. Potential risk class of the medical device
6. Code of type of medical device (according to the nomenclature of medical devices of the Eurasian Economic Union, the rules for maintaining which are approved by Decision of the Board of the Eurasian Economic Commission of December 29, 2015 N 177)
7. Number of the registration certificate of the medical device of the Eurasian Economic Union
8. Information on the documents confirming payment for the procedure of amendments to the registration dossier in the reference state and the procedure of approval of the expert opinion in the states of recognition, as well as issuance of the registration certificate of the medical device in the reference state (if necessary)
9. Method of receiving notifications (decisions) from the authorized body (expert organization) of the reference state	personally signed by registered mail with return receipt requested electronically (when selecting this method, it is necessary to specify the e-mail address(es) to which notifications should be sent) in the form of an electronic document signed with an electronic signature
10. Method of obtaining the registration certificate of a medical device and (or) its annex (in case the changes introduced will entail changes in the registration certificate of a medical device and (or) its annex), as well as the previously issued registration certificate of a medical device and (or) its annex with a note on their invalidity	in person on paper by registered mail with return receipt requested

due to the following changes:

Amendments to the registration dossier of a medical device

N n/a	Revision before changes	Changes to be made
1.	…	…

Changes in the registration dossier do not entail changes in the properties and characteristics affecting the safety, quality and efficacy of the medical device.

I guarantee the accuracy of the information provided.

I guarantee the preservation of the declared characteristics of safety and effectiveness of the medical device during the entire service life if the conditions of operation, transportation and storage of the medical device are observed in accordance with the manufacturer’s requirements.

___________________________________

(date of application)

__________________________________________

(full name and position of the head of the manufacturer (authorized representative of the manufacturer))

___________________________________________

(signature, stamp of the manufacturer (authorized representative of the manufacturer))

Annex N 8

to the Rules for Registration and Examination

Safety, quality and efficiency

medical devices

EXPERT OPINION

ON THE POSSIBILITY (IMPOSSIBILITY) OF MAKING CHANGES

IN THE REGISTRATION DOSSIER OF A MEDICAL DEVICE

_______________________________________________________________________________________

(name of the authorized body (expert organization) of the reference state)

APPROVED

____________________________________

(full name of the head of the authorized body

(expert organization), signature, stamp)

EXPERT OPINION

             on the possibility (impossibility) of making changes

               in the registration dossier of a medical device

                 N _____ dated «__» _________________ 20__.

    1. Name of medical device.

    2.   Manufacturer of the medical device (full and abbreviated

names, legal form of the legal entity, place of

location (address of a legal entity, place of residence of an individual,

registered as an individual entrepreneur)).

    3.  Authorized representative of the manufacturer (full and abbreviated

names, legal form of the legal entity, place of

location (address of a legal entity, place of residence of an individual,

registered as an individual entrepreneur))

(if available).

    4.   Production sites (full and abbreviated names,

organizational-legal form of the legal entity, actual address).

    5. Scope and purpose.

    6.  Type of medical device according to the nomenclature of medical devices

of products of the Eurasian Economic Union, the rules of which are as follows

approved by the Decision of the Board of the Eurasian Economic Commission from 29

December 2015 N 177.

    7. Potential risk class of the medical device.

    8. Number of the registration certificate of the medical device.

    9. Date of issue of the registration certificate of the medical device.

    10. Amendments made:

Data entered in the registration dossier at the time of registration	Changes to be made	Applicant’s rationale for making the change

    11. Analyze and evaluate the data justifying the changes.

    12.  Conclusion on the possibility (impossibility) of making changes to the

the registration dossier of a medical device (in the case of a judgment of

negative conclusion — with justification of reasons).

______________________________________________ _______________________

(full name of the expert, position, academic degree (title) (if any)) (signature)

Annex N 9

to the Rules for Registration and Examination

Safety, quality and efficiency

medical devices

APPLICATION FORM

AMENDMENTS TO THE REGISTRATION DOSSIER OF MEDICAL

PRODUCTS IN A NOTIFICATION PROCEDURE

To the authorized body

of a member state of the Eurasian Economic

Union

__________________________

(name of the reference State)

APPLICATION

on amendments to the registration dossier of a medical deviceon notice

_________________________________________________________________________________________

(full and abbreviated (if any), including company name of the person on whose behalf the changes are made (manufacturer (authorized representative of the manufacturer), legal form of the legal entity)

hereby requests that the registration dossier of the medical device be amended in a notifiable manner

1. Name of medical device
2. Manufacturer of the medical device (full and abbreviated name, organizational and legal form of the legal entity, location (address of the legal entity, place of residence of the individual registered as an individual entrepreneur)
3. Production sites (full name, address)
4. Authorized representative of the manufacturer (if any) (full and abbreviated name, legal form of the legal entity, location (address of the legal entity, place of residence of the individual registered as an individual entrepreneur)
5. Potential risk class of the medical device
6. Code of type of medical device (according to the nomenclature of medical devices of the Eurasian Economic Union, the rules for maintaining which are approved by Decision of the Board of the Eurasian Economic Commission of December 29, 2015 N 177)
7. Number of the registration certificate of a medical device of the Eurasian Economic Union
8. Information on the documents confirming payment for the procedure of making changes to the registration dossier in the notification procedure in the reference state, as well as issuance of the registration certificate of the medical device in the reference state (if necessary)
9. Method of receiving notifications (decisions) from the authorized body (expert organization) of the reference state	personally signed by registered mail with return receipt requested electronically (when selecting this method, it is necessary to specify the e-mail address(es) to which notifications should be sent) in the form of an electronic document signed with an electronic signature
10. Method of obtaining the registration certificate of a medical device and (or) its annex (in case if the changes introduced will entail changes in the registration certificate of a medical device and (or) its annex), as well as the previously issued registration certificate of a medical device and (or) its annex with a note on their invalidity	in person on paper by registered mail with return receipt requested
Information to be filled in when changes are made by the manufacturer of medical devices of potential application risk class 1 and non-sterile medical devices of potential application risk class 2a, who has evaluated the quality management system of medical devices, including design and development processes, in accordance with the Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices depending on the potential risk of their use, approved by the Decision of the Council of the Eurasian Economic Commission from 10 N 106:
11. number of the report on the results of the initial production inspection
12. name of the inspecting organization that carried out the initial inspection of production
13. Number of the report on the results of periodic (scheduled) inspection of production (if any)
14. Name of the inspecting organization that conducted periodic (scheduled) inspection of production

due to the following changes:

Amendments to the registration dossier of a medical device

N n/a	Revision before changes	Changes to be made
1.	…	…

Changes in the registration dossier do not entail changes in the properties and characteristics affecting the safety, quality and efficacy of the medical device.

I guarantee the accuracy of the information provided.

I guarantee the preservation of the declared characteristics of safety and effectiveness of the medical device during the entire service life if the conditions of operation, transportation and storage of the medical device are observed in accordance with requirements of the manufacturer.

______________________________________________

(full name and position of the head of the manufacturer

(authorized representative of the manufacturer))

______________________________________________

(signature, stamp of the manufacturer

(authorized representative of the manufacturer))

Annex N 10

to the Rules for Registration and Examination

safety, quality and efficiency

medical devices

APPLICATION FORM

ON ISSUANCE OF A DUPLICATE REGISTRATION CERTIFICATE

MEDICAL DEVICE

To the authorized bodyof a member state

of the Eurasian Economic Union

___________________________

(name of the reference State)

APPLICATION

on issuance of a duplicate registration certificate for a medical device

1. Number of the registration certificate of the medical device
2. Name of the medical device (indicating the model (brand) of the medical device, its composition and accessories — as an attachment to the application, stamped and signed by the head of the manufacturer of the medical device)

I. Information on the manufacturer of the medical device

3. legal form and full name of the legal entity or surname, name, patronymic (if any) of the individual registered as an individual entrepreneur
4. Abbreviated name of the legal entity (if any)
5. Firm name of the legal entity (if any)
6. Location (address of a legal entity, place of residence of an individual registered as an individual entrepreneur)
7. Phone number
8. E-mail address of a legal entity or an individual registered as an individual entrepreneur (if any)
9. Taxpayer Identifier
10. Production sites (full name, address)

II. Information on the manufacturer’s authorized representative (if any)

11. legal form and full name of the legal entity or surname, name, patronymic (if any) of the individual registered as an individual entrepreneur
12. Abbreviated name of the legal entity (if any)
13. Firm name of the legal entity (if any)
14. Location (address of a legal entity, place of residence of an individual registered as an individual entrepreneur)
15. Phone number
16. E-mail address of a legal entity or an individual registered as an individual entrepreneur (if any)
17. Taxpayer Identifier

III. Other information

18. Method of receiving notifications (decisions) from the authorized body (expert organization) of the reference state	personally signed by registered mail with return receipt requested electronically (when selecting this method, it is necessary to specify the e-mail address(es) to which notifications should be sent) in the form of an electronic document signed with an electronic signature
19. Method of obtaining a duplicate of a registration certificate of a medical device	in person on paper by registered mail with return receipt requested
20. Grounds for issuance of a duplicate	loss of registration certificate defacement of registration certificate
21. Information on the document confirming payment for issuance of the duplicate (date and number of the payment order)

____________________

(date of application)

________________________________________________

(full name and position of the head of the manufacturer (authorized representative of the manufacturer))

________________________________________________

(signature, stamp of the manufacturer (authorized representative of the manufacturer))

Annex N 11

to the Rules for Registration and Examination

safety, quality and efficiency

medical devices

APPLICATION

FORM ON THE HARMONIZATION OF THE EXPERT OPINION

ON A REGISTERED MEDICAL DEVICE

To the authorized body

(expert organization) of a member state of

the Eurasian Economic Union

___________________________

(name of the reference State)

___________________________

(name of the State(s) of recognition not specified

in the registration certificate of the medical device

APPLICATION

on approval of an expert opinion on a registered medical device

___________________________________________________________________________________

(full and abbreviated (if any), including company name of the person on whose behalf the application is submitted (manufacturer (manufacturer’s authorized representative), legal form of the legal entity)

hereby requests the procedure for approval of the expert opinion on the registered medical device:

1. Name of medical device
2. Details of the registration certificate of the medical device
3. Potential risk class of the medical device
4. Code of the type of medical device (according to the nomenclature of medical devices of the Eurasian Economic Union, the rules for maintaining which are approved by the Decision of the Board of the Eurasian Economic Commission of December 29, 2015 N 177)
5. Full name and country of the manufacturer, including location (address of a legal entity, place of residence of an individual registered as an individual entrepreneur)
6. Full names of production sites, including address
7. Name of the manufacturer’s authorized representative in the territories of member states of the Eurasian Economic Union, including location (address of a legal entity, place of residence of an individual registered as an individual entrepreneur)
8. Information on the document confirming payment for issuance of the registration certificate in the reference state (if necessary)
9. Information on the document confirming payment for the procedure of approval of the expert opinion on the registered medical device in the State(s) of recognition
10. Method of receipt of notifications (decisions) from the authorized body (expert organization) of the reference state:	personally signed by registered mail with return receipt requested electronically (when selecting this method, it is necessary to specify the e-mail address(es) to which notifications should be sent) in the form of an electronic document signed with an electronic signature
11. Method of obtaining a registration certificate for a medical device and its annexes:	in person on paper by registered mail with return receipt requested

I guarantee the truthfulness and identity of the information contained in the application.

____________________

(date of application)

________________________________________

(full name and position of the head of the manufacturer

(authorized representative of the manufacturer))

________________________________________

(signature, stamp of the manufacturer

(authorized representative of the manufacturer))

Annex N 12

to the Rules for Registration and Examination

safety, quality and efficiency

medical devices

LIST

DOCUMENTS REQUIRED FOR THE PROCEDURE

APPROVAL OF THE EXPERT REPORT ON THE REGISTERED

MEDICAL DEVICE

Name of the document	Note
1. Application for approval of an expert opinion on a registered medical device	in the form provided by Annex N 11 to the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices, approved by the Decision of the Council of the Eurasian Economic Commission of February 12, 2016. N 46
2. Contract of the manufacturer with the authorized representative of the manufacturer or its copy (if there is an authorized representative of the manufacturer)	the copy shall be certified in accordance with international standards of certification or the standards of certification established by the legislation of the reference state
3. Power of attorney from the manufacturer or authorized representative of the manufacturer for the right to represent interests during the procedure of approval of the expert opinion on the registered medical device (if necessary)	in accordance with international assurance standards or assurance standards established in accordance with the legislation of a member state of the Eurasian Economic Union
4. Data on labeling and packaging approved during registration of the medical device taking into account the changes made in the registration dossier of the medical device (full-color (with indication of color coding) layouts of packages and labels), the text of labeling in the state languages of the states of recognition specified in the application for approval of the expert opinion on the registered medical device) (if necessary)	are certified by the manufacturer (authorized representative of the manufacturer)
5. operating document or instructions for use of the medical device, service manual, approved at the time of registration of the medical device, taking into account the changes made in the registration dossier of the medical device, in the state languages of the states of recognition, specified in the application for the approval of the expert opinion on the registered medical device (if necessary)	are certified by the manufacturer (authorized representative of the manufacturer)
6. Registration certificate of a medical device of the Eurasian Economic Union or a duplicate thereof

Annex N 13

to the Rules for Registration and Examination

safety, quality and efficiencymedical devices

APPLICATION FORM

ON REVOCATION (ANNULMENT) OF THE REGISTRATION

MEDICAL DEVICE AUTHORIZATION

To the authorized bodyof a member state

of the Eurasian Economic Union

___________________________

(name of the reference State)

APPLICATION

Cancellation (revocation) of the registration certificate of a medical device

_______________________________________________________________________________

(full and abbreviated (if any), including company name of the person on behalf of whom the application is submitted (manufacturer (manufacturer’s authorized representative), legal form of the legal entity)

hereby requests to cancel the validity of the registration certificate of the medical device (cancel the registration certificate of the medical device)

_______________________________________________________________________________

(name of the medical device (specifying the model (brand) of the medical device, its composition and accessories))

_______________________________________________________________________________

(date of registration of the medical device and number of the registration certificate of the medical device)

in

connection

with

________________________________________________________

(insert reason)

_____________________

(date of application)

________________________________________________________

(full name and position of the head of the manufacturer (authorized representative of the manufacturer))

________________________________________________________

(signature, stamp of the manufacturer (authorized representative of the manufacturer))