DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of July 24, 2018 No. 116

About Criteria of differentiation of the elements of medical product which are components of medical product for the purpose of its registration

Based on Item 2 of Article 3, Items 2 and 4 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014 and Item 11 of Rules of registration and examination of safety, quality and efficiency of the medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 46, and also according to Item 23 of the list of acts of the Eurasian economic commission on questions of regulation of the total markets of medicines and medical products within the Eurasian Economic Union for 2017-2019 (No. 15) the Board of the Eurasian economic commission solved appendix to the order of Council of the Eurasian economic commission of May 17, 2017:

1. Approve the enclosed Criteria of differentiation of the elements of medical product which are components of medical product for the purpose of its registration.

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

Approved by the Decision of Board of the Eurasian economic commission of July 24, 2018 No. 116

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