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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 10, 2017 No. 106

About Requirements to implementation, maintenance and assessment of quality management system of medical products depending on potential risk of their use

According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, Item 1 of article 6 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, Item 107 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 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 prescription and medical equipment) within the Eurasian Economic Union" Council of the Eurasian economic commission solved No. 109:

1. Approve the enclosed Requirements to implementation, maintenance and assessment of quality management system of medical products depending on potential risk of their use (further – Requirements).

2. Determine that:

a) within 12 months from the date of the introduction of this Decision in force:

assessment of quality management system of the producer of medical product on compliance to Requirements is not carried out;

in case of filing of application about registration of medical product of class of potential risk of use 2a (for the medical products issued in sterile type), 2b or 3 as a part of the registration file the documents confirming availability at the producer of medical product of the conditions of production of the medical product declared for registration conforming to requirements of the legislation of state member of the Eurasian Economic Union to which authorized body the specified application (in the presence of such requirements), and copies of certificates of conformity of quality management system to requirements of the state standard specification ISO13485 standard "Products medical is submitted are submitted. Quality management system. System requirements for the purposes of regulation" or the corresponding national (state) or international standard, and also the copy of reports on earlier carried out inspections on compliance to the ISO13485 standard (in the presence);

b) producers of the medical products registered within 12 months from the date of the introduction of this Decision in force according to the Rules of registration and examination of safety, quality and efficiency of medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 46, shall confirm implementation of quality management system by passing of unplanned inspection of production according to Requirements within 2 years from registration date of medical product;

c) paragraphs the third and fourth Item 3 of Requirements become effective from the effective date regulations on entering of corresponding changes into the Rules of registration and examination of safety, quality and efficiency of medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 46.

3. Investment of the inspecting organizations with powers for conducting inspections of producers of medical products is performed by the public authority of state member of the Eurasian Economic Union authorized on implementation and (or) coordination of activities in the field of the address of medical products in the territory of this state according to the requirements to such organizations approved by the Eurasian economic commission.

4. This Decision becomes effective after 10 calendar days from the date of its official publication.

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

A. Mamin

From the Kyrgyz Republic

T. Abdygulov

From the Russian Federation

I. Shuvalov

 

Approved by the Decision of Council of the Eurasian ekonomicheskoykomissiya of November 10, 2017 No. 106

Requirements to implementation, maintenance and assessment of quality management system of medical products depending on potential risk of their use

I. General provisions

1. These Requirements are developed according to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014 and Item 1 of article 6 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014 and establish within the Eurasian Economic Union (further – the Union) requirements to implementation, maintenance and assessment of quality management system of medical products depending on potential risk of their use.

2. For the purposes of these Requirements ispolzuyutsyaponyatiya which mean the following:

"production inspection" – otsenkausloviya of production and quality management system of the producer of medical izdeliyan compliance to these Requirements;

"the inspecting organization" – authorized body or the organization (organizations) which, (which) authorized body of state member of the Union delegates powers on conducting inspection of production;

"corrective action" – the action taken by the producer of medical products for the purpose of elimination of the reason of the found discrepancy or undesirable event;

"correction" – action taken for the purpose of elimination of the found discrepancy;

"the critical supplier" – the supplier, products or services of which exert direct impact on safety and (or) efficiency of medical product;

"the poor-quality medical product" – medical product which does not conform to general requirements of safety and efficiency of medical products to requirements to their marking, technical and operational documentation on them and cannot be safely used for designated purpose, established by the producer;

"assessment of quality management system of medical product" – confirmation of implementation, maintenance and effectiveness of functioning of quality management system of medical products for ensuring compliance to General requirements of safety and efficiency of medical products, requirements to their marking, technical and operational documentation, applicable to them, on them approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 27 released within the Union of medical products;

"post-sale monitoring" – system of collection and data analysis of the producer of medical products about use of medical products, tracking and identification of side effects of medical products in the course of their operation;

"the warning action" – action taken for the purpose of elimination of the reason of potential discrepancy or potentially undesirable situation;

"production site" – territorially isolated complex intended for accomplishment of all production process of medical product or its certain stages;

"quality management system of medical products" – organizational structure, functions, the procedures, processes and resources necessary for the coordinated activities for management and management of the organization – producer of medical products in relation to quality;

"authorized body" – the public authority of state member of the Union authorized on implementation and (or) coordination of activities in the field of the address of medical products in the territory of this state;

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