Decision of the Board of the Eurasian Economic Commission dated December 29, 2015 N. 177
«On the Rules for Maintaining the Nomenclature of Medical Devices»
BOARD OF THE EURASIAN ECONOMIC COMMISSION
DECISION
of December 29, 2015 N 177
ON THE RULES FOR MAINTAINING THE NOMENCLATURE OF MEDICAL DEVICES
In accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of May 29, 2014, the second paragraph of paragraph 4 of Article 4 of the Agreement on common principles and rules of circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union of December 23, 2014, paragraph 24 of Annex N 2 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 December 23, 2014
1. To approve the attached Rules for maintaining the nomenclature of medical devices.
2 Determine the Federal Service for Supervision of Health Care as the operator of the nomenclature of medical devices of the Eurasian Economic Union.
3. the Eurasian Economic Commission, together with the authorized bodies of the member states of the Eurasian Economic Union in the field of health care, to consider the creation of a working group to coordinate work on the creation and maintenance of the nomenclature of medical devices of the Eurasian Economic Union.
4. This Decision shall enter into force after 30 calendar days from the date of entry into force of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union dated December 23, 2014 or 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 for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union.
Chairman of the Board
Eurasian Economic Commission
V. CHRISTENKO
Approved
By the decision of the Board of the Eurasian
economic commission
dated __________ 20__. N _____
RULES FOR MAINTAINING THE NOMENCLATURE OF MEDICAL DEVICES
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 the second paragraph of Article 4, paragraph 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, apply to medical devices registered within the Eurasian Economic Union (hereinafter — the Union), and determine the procedure for the formation and maintenance of the nomenclature of medical devices of the Union.
2. For the purposes of these Regulations, the terms used shall mean the following:
«Agency of the Global Nomenclature of Medical Devices» is the organization responsible for the formation and maintenance of the Global Nomenclature of Medical Devices;
«type of medical device» means a set of medical devices having the same or similar purpose and (or) device;
«Global Medical Device Nomenclature» (Global Medical Device Nomenclature) — a systematized nomenclature classifier of types of medical devices, used for the purpose of identification of medical devices;
«Union nomenclature of medical devices» means a systematized nomenclature classifier of types of medical devices, harmonized with the Global Nomenclature of Medical Devices and applied within the Union.
II. Procedure for forming and maintaining the nomenclature
medical devices of the Union
3 The Nomenclature of medical devices of the Union shall contain a list of types of medical devices with indication of nomenclature names, unique codes and descriptions of types of medical devices, including classification features of medical devices depending on the purpose of medical devices and (or) their device.
4. The name and description of each type of medical devices included in the Nomenclature of Medical Devices of the Union shall correspond to the name and description of the type of medical devices included in the Global Nomenclature of Medical Devices.
5. For the purposes of systematization of types of medical devices included in the Nomenclature of Medical Devices of the Union, the categories of medical devices included in the Global Nomenclature of Medical Devices shall be used.
6. The nomenclature of medical devices of the Union is part of the unified system of normative and reference information of the Union, formed in accordance with paragraphs 4, 5 and 7 of the Protocol on Information and Communication Technologies and Information Interaction within the Eurasian Economic Union (Annex N 3 to the Treaty on the Eurasian Economic Union of May 29, 2014).
7. The nomenclature of medical products of the Union is formed and maintained by the operator of the nomenclature of medical products of the Union in electronic form, is placed by the Eurasian Economic Commission (hereinafter — the Commission) on the information portal of the Union in the information and telecommunication network «Internet» (hereinafter — the Internet), is publicly available and is provided to users on a free of charge and non-discriminatory basis.
8. The operator of the nomenclature of medical devices of the Union shall perform the following functions:
a) ensures translation into Russian of the names of types of medical devices and descriptions of their types included in the Global Nomenclature of Medical Devices and enters them into the Nomenclature of Medical Devices of the Union with assignment of unique codes;
b) ensure translation into Russian of the names of new types of medical devices and descriptions of their types received from the Agency of the Global Nomenclature of Medical Devices, as well as information on changes made to the names of types of medical devices and descriptions of their types included in the Global Nomenclature of Medical Devices, and make appropriate changes to the nomenclature of medical devices of the Union;
c) ensures assignment of unique codes to new types of medical devices included in the nomenclature of medical devices of the Union;
d) on the basis of information received from the Agency of the Global Nomenclature of Medical Devices on exclusion of certain types of medical devices from the Global Nomenclature of Medical Devices, ensures exclusion of the relevant types of medical devices and descriptions of their types from the Nomenclature of Medical Devices of the Union;
e) sends, using the means of the integrated information system of the Union, to the Commission information on changes made to the nomenclature of medical devices of the Union for its updating on the information portal of the Union on the Internet;
(e) considers appeals and requests of users of the nomenclature of medical devices of the Union concerning its application;
g) analyze and generalize the comments and proposals of the users of the nomenclature of medical devices of the Union on its structure and content;
h) form and submit for consideration of the Commission, based on the results of analysis of comments and proposals of users of the nomenclature of medical devices of the Union, proposals for amendments to these Rules.
9. The authorized bodies of the Union Member States shall conclude agreements with the Agency of the Global Nomenclature of Medical Devices on the use of original codes of types of medical devices included in the Global Nomenclature of Medical Devices, as well as on the inclusion of new types of medical devices in the Global Nomenclature of Medical Devices.