BOARD OF THE EURASIAN ECONOMIC COMMISSION

DECISION
of 29 December 2015 No. 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 29 May 2014, the second paragraph of paragraph 4 of Article 4 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of 23 December 2014, paragraph 24 of Annex No. 2 to the Rules of Procedure of the Eurasian Economic Commission approved by Decision of the Supreme Eurasian Economic Council of 23 December 2014 No. 98, and for the purpose of implementing Decision of the Supreme Eurasian Economic Council of 23 December 2014 No. 109 "On the Implementation of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union", the Board of the Eurasian Economic Commission has decided:

1. To approve the attached Rules for Maintaining the Nomenclature of Medical Devices.

2. To designate the Federal Service for Surveillance in Healthcare as the operator of the Nomenclature of Medical Devices of the Eurasian Economic Union.

3. The Eurasian Economic Commission, jointly with the competent authorities of the EAEU Member States in the field of healthcare, shall consider the establishment of a working group to coordinate activities related to the creation and maintenance of the Nomenclature of Medical Devices of the Eurasian Economic Union.

4. This Decision shall enter into force upon the expiry of 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 Products and Medical Equipment) within the Eurasian Economic Union of 23 December 2014, or from the date of entry into force of the Protocol signed on 2 December 2015 on the Accession of the Republic of Armenia to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of 23 December 2014, whichever is later, but not earlier than upon the expiry of 30 calendar days from the date of official publication of this Decision.

Chairman of the Board
of the Eurasian Economic Commission
V. KHRISTENKO

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Approved
by Decision of the Board of the Eurasian
Economic Commission
of __________ 20__
No. _____

RULES FOR MAINTAINING THE NOMENCLATURE OF MEDICAL DEVICES

I. General Provisions

1. These Rules have been developed in accordance with paragraph 2 of Article 31 of the Treaty on the Eurasian Economic Union of 29 May 2014 and the second paragraph of paragraph 4 of Article 4 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union of 23 December 2014, apply to medical devices registered within the Eurasian Economic Union (hereinafter — the Union), and establish the procedure for the formation and maintenance of the Nomenclature of Medical Devices of the Union.

2. For the purposes of these Rules, the following terms shall have the meanings set out below:

"Global Medical Device Nomenclature Agency" — the organisation responsible for the formation and maintenance of the Global Medical Device Nomenclature;

"type of medical device" — a set of medical devices having a similar or analogous intended purpose and/or design;

"Global Medical Device Nomenclature" (GMDN) — a systematised nomenclature classifier of types of medical devices used for the identification of medical devices;

"Nomenclature of Medical Devices of the Union" — a systematised nomenclature classifier of types of medical devices, harmonised with the Global Medical Device Nomenclature and applied within the Union.

II. Procedure for the Formation and Maintenance of the Nomenclature of Medical Devices of the Union

3. The Nomenclature of Medical Devices of the Union contains a list of types of medical devices specifying nomenclature names, unique codes and descriptions of types of medical devices, including classification criteria for medical devices according to their intended purpose and/or design.

4. The name and description of each type of medical device included in the Nomenclature of Medical Devices of the Union shall correspond to the name and description of that type of medical device as included in the Global Medical Device Nomenclature.

5. For the purposes of systematising the types of medical devices included in the Nomenclature of Medical Devices of the Union, the categories of medical devices included in the Global Medical Device Nomenclature shall be used.

6. The Nomenclature of Medical Devices of the Union forms part of the unified regulatory reference information system of the Union, established 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 No. 3 to the Treaty on the Eurasian Economic Union of 29 May 2014).

7. The Nomenclature of Medical Devices of the Union is formed and maintained by the operator of the Nomenclature of Medical Devices of the Union in electronic form, is published by the Eurasian Economic Commission (hereinafter — the Commission) on the information portal of the Union on 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 the translation into Russian of the names and descriptions of types of medical devices included in the Global Medical Device Nomenclature, and enters them into the Nomenclature of Medical Devices of the Union with the assignment of unique codes;

(b) ensures the translation into Russian of the names and descriptions of new types of medical devices received from the Global Medical Device Nomenclature Agency, as well as information on amendments to the names and descriptions of types of medical devices included in the Global Medical Device Nomenclature, and introduces the corresponding amendments into the Nomenclature of Medical Devices of the Union;

(c) ensures the assignment of unique codes to new types of medical devices included in the Nomenclature of Medical Devices of the Union;

(d) ensures, on the basis of information received from the Global Medical Device Nomenclature Agency on the removal of certain types of medical devices from the Global Medical Device Nomenclature, the removal of the corresponding types of medical devices and their descriptions from the Nomenclature of Medical Devices of the Union;

(e) transmits, using the integrated information system of the Union, to the Commission information on amendments introduced into the Nomenclature of Medical Devices of the Union for the purpose of updating it on the information portal of the Union on the Internet;

(f) considers applications and inquiries from users of the Nomenclature of Medical Devices of the Union concerning its application;

(g) analyses and consolidates comments and proposals from users of the Nomenclature of Medical Devices of the Union regarding its structure and content;

(h) prepares and submits to the Commission, based on the analysis of comments and proposals from users of the Nomenclature of Medical Devices of the Union, proposals for amendments to these Rules.

9. The competent authorities of the EAEU Member States shall conclude agreements with the Global Medical Device Nomenclature Agency on the use of original codes of types of medical devices included in the Global Medical Device Nomenclature, as well as on the inclusion of new types of medical devices in the Global Medical Device Nomenclature.