RESOLUTION OF THE CABINET OF MINISTERS OF THE KYRGYZ REPUBLIC

of August 27, 2024 No. 513

About some questions connected with registration, monitoring of safety, quality and efficiency of medical products, requirements to marking and packaging of medical products

For the purpose of implementation 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:

1) the Procedure for state registration, conducting examination of safety, quality and efficiency of medical products, maintaining the State register, nomenclature of medical products, modification of the registration file of medical products, suspensions or cancellations of action (cancellation) of the registration certificate according to appendix 1;

2) the Procedure for carrying out monitoring of safety, quality and efficiency of medical products according to appendix 2.

2. Determine that:

1) classification of medical products depending on potential risk of application is performed according to the Rules of classification of medical products depending on potential risk of application approved by the decision of Board of the Eurasian economic commission of December 22, 2015 No. 173;

2) requirements for safety and efficiency of medical products are shown according to the General requirements of safety and efficiency of medical products, requirements to their marking and operational documentation on them approved by the decision of Council of the Eurasian economic commission of February 12, 2016 No. 27, except for of Item 63 of the specified General requirements of safety and efficiency of medical products, requirements to their marking and operational documentation on them;

3) testing (research) on purpose estimates of biological effect of medical products are carried out according to the Rules of carrying out researches (testing) for the purpose of assessment of biological effect of medical products approved by the decision of Council of the Eurasian economic commission of May 16, 2016 No. 38;

4) technical testing (researches) of medical products are conducted according to the Rules of carrying out technical testing of medical products approved by the decision of Council of the Eurasian economic commission of February 12, 2016 No. 28;

5) clinical and clinical laboratory testing (researches) of medical products are conducted according to the Rules of carrying out clinical and clinical laboratory testing (researches) of medical products approved by the decision of Council of the Eurasian economic commission of February 12, 2016 No. 29.

3. Recognize invalid:

1) the order of the Government of the Kyrgyz Republic "About some questions connected with registration of medical products" of July 5, 2018 No. 311;

2) the order of the Government of the Kyrgyz Republic "About approval of the Procedure for carrying out monitoring of quality, safety and efficiency of medical products and modification of some decisions of the Government of the Kyrgyz Republic concerning monitoring of side effects of the registered products of medical appointment, medical implants and products for diagnostics" of August 1, 2018 No. 359.

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

Appendix 1

To the resolution of the Cabinet of Ministers of the Kyrgyz Republic of August 27, 2024 No. 513

Procedure for state registration, conducting examination of safety, quality and efficiency of medical products, maintaining the State register, nomenclature of medical products, modification of the registration file of medical products, suspensions or cancellations of action (cancellation) of the registration certificate

Chapter 1. General provisions

1. This Procedure determines procedures of state registration, conducting examination of safety, efficiency and quality of medical products, preparation of the conclusion, issue of the registration certificate, and also the procedure of modification of the registration file of medical products, rules of maintaining the nomenclature of medical products and procedure for maintaining the State register of medical products, suspensions or cancellations of action (cancellation) of the registration certificate.

2. In this Procedure the following concepts are used:

validation - confirmation by means of submission of the objective certificates of fulfillment of requirements intended for specific use or application;

verification - confirmation on the basis of submission of objective certificates of accomplishment of the established requirements;

type of medical product - set of the medical products having similar or similar appointment and (or) the device;

The global nomenclature of medical products (Global Medical Device Nomenclature) - the systematized nomenclature qualifier of types of medical products used for the purpose of identification of medical products;

the applicant - person filing in authorized body the registration application of medical products, modification of the registration file of medical products;

model of medical product - the kind of medical product having general with the main medical product the constructive signs developed based on the main product for the purpose of its enhancement, expansion or specialization of application in the medical purposes;

the nomenclature of medical products - the systematized nomenclature qualifier of medical products containing list of types of medical products with indication of nomenclature names, unique codes and the description of types of the medical products including classification signs of medical products depending on purpose of medical products and (or) their devices;

accessory - the product which is not medical product, intended by the producer for combined use with one or several medical products for use according to their appointment;

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

registration number - the specification symbol appropriated to medical products in case of their registration under which they are entered in the state register of the medical products registered in the Kyrgyz Republic;

the authorized representative of producer - the legal entity or physical person registered as the individual entrepreneur, which is resident of the Kyrgyz Republic and authorized 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 and execution of the mandatory requirements imposed to medical products.

3. Registration of medical products is performed by subordinated division of authorized state body of the Kyrgyz Republic on regulation of the sphere of drug circulation and medical products (further - authorized body).

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info