of July 5, 2018 No. 313
About approval of the Procedure for evaluating quality and safety of medical products
For the purpose of implementation of article 11 of the Law of the Kyrgyz Republic "About the address of medical products", according to articles 10 and 17 of the constitutional Law of the Kyrgyz Republic "About the Government of the Kyrgyz Republic" the Government of the Kyrgyz Republic decides:
1. Approve the Procedure for evaluating quality and safety of medical products according to appendix.
2. Bring in the Order of the Government of the Kyrgyz Republic "About approval of the Technical regulation "About Safety of Products of Medical Prescription" of February 1, 2012 No. 74 the following changes:
- the second offer of Item 3 to exclude;
in the Technical regulation "About Safety of Products of Medical Prescription" approved by the above-stated Resolution:
- to recognize Chapter 8 and appendix 5 invalid.
3. To the Ministry of Health of the Kyrgyz Republic:
- bring the decisions into accord with this resolution;
- take the necessary measures following from this resolution;
- make in accordance with the established procedure offers on modification of the Unified register (list) of the state services rendered by state bodies, their structural divisions and subordinated organizations, No. 85 approved by the Order of the Government of the Kyrgyz Republic of February 10, 2012.
4. To impose control of execution of this Resolution on department of social development of Government office of the Kyrgyz Republic.
Prime Minister of the Kyrgyz Republic
Approved by the Order of the Government of the Kyrgyz Republic of July 5, 2018, No. 313
1. This Procedure for evaluating quality and safety of medical products (further - the Procedure) establishes procedures of evaluating quality and safety of the medical products imported on the territory of the Kyrgyz Republic and made in the Kyrgyz Republic the refusal bases in issue of the conclusion about quality and safety of medical product.
2. In this Procedure the following concepts are used:
- the applicant - the legal entity who addressed with the request for evaluating quality and safety of medical product;
- the conclusion about quality and safety of medical product - the document issued by results of the carried-out quality evaluation and safety of medical product, certifying that the medical product conforms to the established requirements of the regulating document for quality and safety;
- EEU - the Eurasian Economic Union;
- identification of batch - establishment of compliance of batch of medical products to shipping documents;
- the regulating document on quality and safety of medical products - the document (international, regional), the national standard, the standard of the organization establishing complex of quality requirements, to safety, transportation and storage of medical products and also to techniques of its testing;
- sample of medical product - the medical product intended for carrying out technical and clinical testing;
- batch - the part of series of medical products which arrived from one sender according to one transport document;
- series of product of medical prescription - the set of assigned amount of one or more components of product of medical prescription or product of medical prescription from one type, model, type, the size, structure made in identical conditions, having identical characteristics and quality in the set limits.
3. The quality evaluation and safety of medical products is performed for establishment of compliance of quality and safety of specific series (batches) of medical products to requirements of the regulating document for quality and safety.
4. Are exposed to quality evaluation and safety of medical products taking into account class of potential risk of use of medical products:
1) the registered medical products:
- sterile medical products irrespective of class of potential risk of use on sterility indicators;
- medical products of class of potential risk of use 1 and 2a, contacting to blood and internal cavities of human body, on safety indicators;
- medical products of class of potential risk of use 2b and 3 on safety indicators;
2) the medical products included in the list of medical products which import and use in the territory of the Kyrgyz Republic are resolved without registration.
5. The quality evaluation and safety of medical products is performed by the subordinated organization regulating drug circulation and products of medical prescription, authorized state body of the Kyrgyz Republic in the field of health care (further - authorized body).
6. The quality evaluation and safety of medical products includes carrying out the following procedures:
- giving by the applicant in authorized body of the request for evaluating quality and safety of medical products and check of completeness of the filed documents;
- identification of batch of medical products;
- sampling of medical products;
- information analysis in the submitted documents, and also markings and packagings of medical products on compliance to the regulating document on quality and safety;
- testing of samples of medical products for compliance to the regulating document on quality and safety;
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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