DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of July 24, 2018 №123

About Criteria of inclusion in one registration certificate of several modifications of medical product relating to one type of medical product according to the nomenclature of medical products applied in the Eurasian Economic Union

Based on Item 2 of Article 3,Items 2 and 4of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014 and Item 14 of Rules of registration and examination of safety, quality and efficiency of the medical products approved by the Decision of Council of the Euroasian economic commission of February 12, 2016 №. 46, and also according to Item 21 of the list of acts of the Euroasian economic commission on questions of regulation of the total markets of medicines and medical products within the Eurasian Economic Union for 2017 - 2019 (№ 15) the Board of the Euroasian economic commission decided appendix to the order of Council of the Euroasian economic commission of May 17, 2017:

1. Approve the enclosed Criteria of inclusion in one registration certificate of several modifications of medical product relating to one type of medical product according to the nomenclature of medical products applied in the Eurasian Economic Union.

2. This Decision becomes effective after 30 calendar days from the date of its official publication.

Approved by the Decision of Board of the Euroasian economic commission of July 24, 2018 №123

Criteria of inclusion in one registration certificate of several modifications of medical product relating to one type of medical product according to the nomenclature of medical products applied in the Eurasian Economic Union

1. This document establishes criteria of inclusion in one registration certificate of several modifications of medical product relating to one type of medical product according to the nomenclature of medical products applied in the Eurasian Economic Union.

2. For the purposes of use of this document the concepts determined by the Rules of maintaining the nomenclature of medical products approved by the Decision of Board of the Euroasian economic commission of December 29, 2015 №. 177, the Rules of carrying out clinical and clinical laboratory testing (researches) of medical products approved by the Decision of Council of the Euroasian economic commission of February 12, 2016 № 29, and the Rules of registration and examination of safety, quality and efficiency of medical products approved by the Decision of Council of the Euroasian economic commission of February 12, 2016 № 46 are used.

3. Inclusion in one registration certificate of several modifications of medical product relating to one type of medical product according to the nomenclature of medical products applied in the Eurasian Economic Union is possible on condition of compliance of these modifications to all following criteria:

a) production of modifications of medical product is performed by one producer of medical product according to one technical documentation;

b) modifications of medical product belong to one class of potential risk of use;

c) availability and (or) quantitative content in biological test same clinically (diagnostically) significant anolyte (anolytes) (for medical products for diagnosis of i№vitro);

d) modifications of medical product have the different pickings which are not influencing the principle of work and functional purpose that allows to provide expansion or specialization of their use in the medical purposes (on applicability);

e) modifications of medical product have the different technical parameters (for example, the radiation wavelength, the size of the light field, resolving power, etc.) which are not influencing the principle of work and functional purpose (on applicability);

e) modifications of medical product form tiporazmerny row (for example, have the different sizes (dimensional, linear, volume, etc.), form, color coding, etc.) or are group of execution of medical product (for example, the stationary portable device (the device, system, complex, etc.) with wall and (or) floor fixture, etc.) (on applicability). At the same time the group of execution of medical product is understood as products concerning which one group drawing of details and (or) one group specification are executed.

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