RESOLUTION OF THE CABINET OF MINISTERS OF THE KYRGYZ REPUBLIC

of October 17, 2024 No. 626

About approval of the Procedure for evaluating quality and safety of medical products

For the purpose of implementation of article 19 of the Law of the Kyrgyz Republic "About the address of medical products", according to articles 13, of the 17th constitutional Law of the Kyrgyz Republic "About the Cabinet of Ministers of the Kyrgyz Republic" the Cabinet of Ministers of the Kyrgyz Republic decides:

1. Approve the Procedure for evaluating quality and safety of medical products according to appendix.

2. Determine that the realization of this resolution is enabled within the approved budget of the Ministry of Health of the Kyrgyz Republic for the corresponding years.

3. Declare invalid the order of the Government of the Kyrgyz Republic "About approval of the Procedure for evaluating quality and safety of medical products" of July 5, 2018 No. 313.

4. This resolution becomes effective after thirty days from the date of official publication.

Appendix

to the Resolution of the Cabinet of Ministers of the Kyrgyz Republic of October 17, 2024 No. 626

Procedure for evaluating quality and safety of medical products

Chapter 1. General provisions

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 territory of the Kyrgyz Republic.

2. 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.

3. In this Procedure the following terms and concepts are used:

1) the applicant - the physical person or legal entity which addressed with the request for the evaluating quality of medical product having the current license on pharmaceutical or medical activities as applicants also the other persons having the rights to import, make or make medical products in the procedure established by the law can act;

2) 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;

3) identification of batch - establishment of compliance of batch of medical products to shipping documents;

4) 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;

5) sample of medical product - the medical product intended for carrying out technical and clinical testing;

6) batch - the part of series of medical products which arrived from one sender according to one transport document;

7) series of product of medical appointment - the set of assigned amount of one or more components of product of medical appointment or product of medical appointment from one type, model, type, the size, structure made in identical conditions, having identical characteristics and quality in the set limits;

8) authorized body - the subordinated division of authorized state body of the Kyrgyz Republic in the field of health care regulating drug circulation and medical products;

9) medical products for diagnostics of in vitro - any tools, devices, devices, the equipment, materials, reagents, calibrators, control materials and other products applied in the medical purposes separately or in combination among themselves and also together with the accessories necessary for application of the specified products to destination (including the special software), and information of rather physiological or pathological condition, congenital pathology, predisposition to certain clinical condition or disease, compatibility of fabrics with the potential recipient intended by the producer for application in case of the researches in vitro of samples of biological materials of the person for obtaining, forecasting of reactions to therapeutic impacts, the choice of therapeutic means and (or) control of treatment;

10) quarantine zone of warehouse - the storage location of products isolated physically or otherwise before decision making about their realization, rejection or conversions.

The specific (industry) terms and concepts used in this Procedure and which are not provided in this Chapter are applied in the values provided by acts of the Eurasian Economic Union (further - EEU) in the sphere of the address of medical products.

Chapter 2. Procedure for evaluating quality and safety of medical products

4. The quality evaluation and safety of medical products is performed by authorized body.

5. Are exposed to quality evaluation and safety of medical products:

1) the registered medical products:

- sterile medical products irrespective of class of potential risk of application on sterility indicators;

- medical products of class of potential risk of application 1 and 2a, contacting to blood and internal cavities of human body, on safety indicators;

- medical products for diagnostics of in vitro of class of potential risk 2b and 3 are subject to quality evaluation and safety only documentary, except for: sets of reagents for the immunofermental analysis (IFA) and rapid tests of the human immunodeficiency virus (HIV), sets of reagents for IFA and rapid tests for hepatitis C, sets of regents for IFA and rapid tests for hepatitis B, sets of reagents for IFA and rapid tests for syphilis, sets of reagents for IFA and rapid tests for Covid-19;

- medical products of class of potential risk of application 2b and 3 on safety indicators, except for: X-ray - the diagnostic equipment, angiographic complexes, tomographic complexes (computer tomography and magnetic and resonant tomography), ultrasonic complexes;

2) the medical products included in the list of medical products which import and application in the territory of the Kyrgyz Republic are resolved without registration;

3) the medical products for diagnostics of in vitro included in the list of medical products which import and application in the territory of the Kyrgyz Republic are resolved without registration are subject to quality evaluation and safety only documentary.

6. Documents acceptance for evaluating quality and safety of medical products, is performed in electronic form, by electronic transfer of documents and information between the applicant and authorized body by means of information system of authorized body.

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