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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of February 12, 2016 No. 28

About approval of Rules of carrying out technical testing 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, and 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 solved No. 109:

1. Approve the enclosed Rules of carrying out technical testing 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 February 12, 2016 No. 28

Rules of carrying out technical testing of medical products

I. General provisions

1. These rules are developed 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 for the purpose of implementation of the specified Agreement and establish within the Eurasian Economic Union (further - the Union) rules of carrying out technical testing of medical products, requirements to the authorized organizations having the right to carry out technical testing of medical products, and also evaluation procedure of compliance of authorized organizations to these requirements.

2. Technical testing of medical products are carried out according to these rules for the purpose of determination of compliance of medical products to general requirements of safety and efficiency of medical products, to requirements to their marking and operational documentation on them approved by the Eurasian economic commission (further - general requirements).

When carrying out technical testing the standards included in the list of standards as a result of which application on voluntary basis observance of compliance of medical product to general requirements is fully or partially provided (further - the list of standards) and also technical documentation of the producer of medical product can be used.

In case of lack of the standards included in the list of standards for the purpose of carrying out technical testing of medical products methods (techniques) of testing certified (validirovanny) and approved according to the legislation of state members of the Union can be applied (further - state members).

3. Technical testing of medical product are carried out according to statements of producers of medical products or their authorized representatives in organizations, the organizations and at the companies which are included by the public authorities authorized on implementation and (or) coordination of activities in the field of the address of medical products in the territories of state members (further - authorized bodies), to the list of the organizations having the right to conduct researches (testing) of medical products for the purpose of their registration (further respectively - the list of the organizations, authorized organizations).

For the purpose of application of these rules the authorized representative of the producer is understood as the legal entity or physical person registered as the individual entrepreneur being residents of state member and representatives according to the power of attorney of the producer of medical product to represent its interests and to bear responsibility regarding the address of medical product within the Union and execution of the mandatory requirements imposed to medical products.

4. For the purpose of receipt of proofs of compliance of medical product to general requirements the applicant has the right to address independently to authorized organizations for the purpose of carrying out technical testing of medical products for compliance to specific standards in full or partially and (or) to the certified (validirovanny) methods (techniques) of testing confirming compliance of medical product to general requirements.

5. Concerning medical products for diagnostics of invitro (reagents, reagents) carrying out technical testing is not recruited.

6. Results of technical testing of medical products are considered negative if the provided samples (sample) of medical product do not conform to the general requirements and standards included in the list of standards on compliance to which testing were carried out.

7. In exceptional cases concerning medical products which transportation to authorized organization is complicated carrying out technical testing by specialists of authorized organization in the territory of producer is allowed.

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