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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

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 are developed according to 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 and establish within the Eurasian Economic Union procedure for carrying out researches (testing) for the purpose of assessment of biological effect of medical products for registration, the requirement to the authorized organizations having the right to conduct researches (testing) for the purpose of assessment of biological effect of medical products (further - authorized organizations), and also evaluation procedure of compliance of authorized organizations to these requirements.

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

"researches on haemo compatibility" - identification of negative biological effects in case of contact of medical product with blood of the person or any of its components;

"pyrogenicity studies" - check of absence in medical products of the chemical agents or other substances capable to cause feverish response (temperature increase of body of the person);

"researches on sterility" - verification of presence or lack of viable microorganisms in medical product;

"material" - any synthetic or natural polymer, metal, alloy, ceramics or other impractical material, including impractical biological fabric, applied as medical product or its part;

"acute system toxicity" - the harmful effect arising at any time after introduction single or repeated doses of the researched test within 24 hours;

"irritant action" - the localized inflammatory reaction of human body to single, repeated or long impact of the researched material without involvement of the immune mechanism;

"specification" - the document executed in the form of the table, determining structure of medical product and containing designations and the description of its components, accessories and consumable materials with indication of names and quantity;

"standard sample" - material with the established indicators of accuracy of measurements and metrological traceability, rather uniform and stable concerning certain properties to use it in case of measurement or in case of estimation of high-quality properties according to expected appointment;

"the authorized representative of the producer" - the legal entity or physical person registered as the individual entrepreneur being residents of state member of the Eurasian Economic Union 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 Eurasian Economic Union and execution of the mandatory requirements imposed to medical products;

"cytotoxicity" - capability of the chemicals which are part of material to cause pathological changes in cells of human body.

3. Researches (testing) for the purpose of assessment of biological effect of medical products (further - testing) are conducted 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 (further - general requirements).

When carrying out 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), technical documentation of the producer of medical product, and also methods (techniques) of testing certified (validirovanny) and approved according to the legislation of state member of the Eurasian Economic Union can be used (further respectively - state members, the Union).

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