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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of May 16, 2016 №38

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

(as amended of the Decision of Council of the Eurasian economic commission of 17.03.2022 No. 26)

According to article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, Items 4 and 5of 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 106of appendix №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 №98, and for the purpose of execution of the Decision of the Supreme Eurasian economic council of December 23, 2014 "About implementation 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" Council of the Eurasian economic commission DECIDED: №109

1. Approve the enclosed Rules of carrying out researches (testing) for the purpose of assessment of biological effect of medical products.

2. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to 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, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Members of council of the Eurasian economic commission:

From the Republic of Armenia

 

V. Gabriyelyan

From the Republic of Belarus

V. Matyushevsky

From the Republic of Kazakhstan

B. Sagintayev

From the Kyrgyz Republic

O. Pankratov

From the Russian Federation

I. Shuvalov

 

Approved by the Decision of Council of the Eurasian economic commission of May 16, 2016 №38

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

I. General provisions

1. These rules establish within the Eurasian Economic Union (further - the Union) procedure for carrying out researches (testing) for the purpose of assessment of biological effect of medical products for registration (further - researches (testing)), including requirements to the authorized organizations having the right to conduct researches (testing) (further - authorized organizations).

2. For the purposes of these rules concepts which mean the following are used:

"category of medical product" - the classification sign of medical product determined in case of the choice of evaluation methods of biological effect of medical product depending on group, type and duration of contact of medical product;

"material" - synthetic or natural polymer, metal, alloy, ceramics or other impractical material, including the impractical biological fabric (which does not have the potential for metabolism or reproduction), applied as medical product or its part;

"sample of medical product" - the product or its representative part which are directly subjected to research (testing);

"standard sample of medical product" - the sample chosen from group of the medical products belonging to one category, made by one producer according to single technical documentation and having identical structure (material), area and conditions of application. At the same time selection of standard samples on structure of medical products shall reflect all set of group of uniform medical products taking into account distinctions in properties of medical products of separate models (brands) in this group.

Other concepts used in these rules are applied in the values determined by acts of bodies of the Union in the sphere of the address of medical products.

3. Researches (testing) are conducted for the purpose of establishment of compliance of medical product to General requirements of safety and efficiency of medical products, to requirements to their marking and the operational documentation on them approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 27 (further - General requirements).

4. When carrying out researches (testing) requirements of the standards included in the list of standards as a result of which application on voluntary basis observance of compliance of medical products to General requirements, and also methods (techniques) of researches (testing) certified (validirovanny) and approved according to the legislation of state member of the Union is fully or partially provided (further - state member) are applied.

5. Researches (testing) are conducted in the test laboratories (centers) chosen as the applicant, data on which are included in the unified register of the authorized organizations having the right to conduct researches (testing) of medical products for the purpose of their registration (further - the register of authorized organizations).

Forming and maintaining the register of authorized organizations are performed by the Eurasian economic commission (further - the Commission) according to the Procedure for forming and maintaining information system in the sphere of the address of medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 30, on the basis of the data represented by the public authorities of state members authorized on implementation and (or) coordination of activities in the sphere of the address of medical products (further - authorized bodies), with use of means of the integrated information system of the Union.

6. Researches (testing) are conducted concerning medical products and (or) accessories to them, directly or indirectly contacting to the surface of body of the person, his mucous membranes, internal circles of organism for which the specified interaction (contact) is necessary for accomplishment of their function.

7. Results of researches (testing) are considered negative if the provided samples (sample) of medical product do not conform to safety requirements.

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