DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of March 17, 2022 No. 26

About modification of Rules of carrying out researches (testing) for the purpose of assessment of biological effect of medical products

According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, items 4 and the 5th 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, Items 105 and 106 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Council of the Eurasian economic commission solved:

1. Bring in the Rules of carrying out researches (testing) for the purpose of assessment of biological effect of medical products approved by the Decision of Council of the Eurasian economic commission of May 16, 2016 No. 38 (further - Rules), changes according to appendix.

2. Determine that:

carrying out researches (testing) for the purpose of assessment of biological effect of medical products according to the civil agreement signed with the authorized organization having the right to conduct such researches (testing), about day of the introduction of this Decision in force is performed according to Rules in the edition operating at the time of the conclusion of this agreement;

the protocols of researches (testing) for the purpose of assessment of biological effect of medical products issued in the form provided by appendix to Rules in the edition operating at the time of the conclusion of the civil agreement are accepted for registration of medical products within the Eurasian Economic Union.

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