ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of July 5, 2018 No. 311

About some questions connected with registration of medical products

For the purpose of implementation 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 state registration of medical products, conducting examination of safety, quality and efficiency of medical products, maintaining the State register of medical products, maintaining the nomenclature of medical products, modification of the registration file of medical products, suspensions of action of the registration certificate.

2. Determine that:

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

- 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;

- testing (research) of medical products for the purpose of 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;

- 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;

- 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. Ceased to be valid according to the Order of the Government of the Kyrgyz Republic of 02.05.2019 No. 200.

4. Bring in the order of the Government of the Kyrgyz Republic "About approval of the Technical regulation "About Safety of Medical Implants" of March 5, 2013 No. 113 the following changes:

in the Technical regulation "About Safety of Medical Implants" approved by the above-named resolution:

- to recognize Chapter 14 and appendix 2 to the above-stated Technical regulation invalid.

5. Bring in the order of the Government of the Kyrgyz Republic "About approval of the Technical regulation "About Safety of Products of Medical and Veterinary Prescription for Laboratory Diagnosis in Artificial Conditions (in Vitro)" of April 5, 2013 No. 173 the following changes:

in the Technical regulation "About Safety of Products of Medical and Veterinary Prescription for Laboratory Diagnosis in Artificial Conditions (in Vitro)" approved by the above-named resolution:

- to recognize Chapter 15 and appendix 4 to the above-stated Technical regulation invalid.

6. 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.

7. To impose control of execution of this resolution on department of social development of Government office of the Kyrgyz Republic.

8. This resolution becomes effective after six months from the date of official publication.

Approved by the Order of the Government of the Kyrgyz Republic of July 5, 2018, No. 311

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

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