ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of August 1, 2018 No. 359

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 prescription, medical implants and products for diagnosis

For the purpose of implementation of article 13 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 carrying out monitoring of quality, safety and efficiency of medical products according to appendix.

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

3. 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 change:

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

- to declare Item 137 of Chapter 15 invalid.

4. 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 change:

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:

- recognize Chapter 18 invalid.

5. 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.

6. This resolution becomes effective after fifteen days from the date of official publication.

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

Appendix

Approved by the Order of the Government of the Kyrgyz Republic of August 1, 2018, No. 359

Procedure for carrying out monitoring of quality, safety and efficiency of medical products

1. This Procedure establishes rules of carrying out monitoring of quality, safety and efficiency of medical products (further - monitoring).

2. The purpose of carrying out monitoring is safety of users, preservation and promotion of health of the population, improvement of quality of delivery of health care, identification and prevention of the side effects and undesirable reactions which are not specified in the application instruction or the operation manual on medical product (further - the application instruction), unfavorable events (incidents), the address of the medical products which are not conforming to General requirements of safety and efficiency of medical products, requirements to their marking and the operational documentation on them approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 27.

3. For the purposes of this Procedure the following concepts are used:

1) the application instruction - the operational documentation containing information provided by the producer to the user concerning appointment, proper and safe use of medical product which can include the operation manual, technique of medical application, the passport, the form, instructions for installation, adjustment, maintenance, repair, transportation, storage, utilization of medical product;

2) corrective action - action taken by the producer of medical products for the purpose of elimination of the reason of the found discrepancy or undesirable event;

3) corrective action on safety of medical product - the action taken by the producer of medical products for the purpose of decrease in risk of death or serious aggravation of symptoms of health of users or the third parties, connected using medical product. Such actions can include:

- return of medical product to the producer, medical products or to his authorized representative;

- modification of medical product (upgrade according to the changes in design of medical product made by the producer of medical products, change of application instructions, updating of the software of medical product);

- replacement of medical product;

- withdrawal of medical product from the address;

- destruction of medical product;

- informing on actions of users of medical products if medical product is withdrawn from circulation, but there is probability of its use;

4) unfavorable event (incident) - any defect and (or) deterioration in characteristics or violation of functioning of medical product, either insufficiency or incorrectness of accompanying information (documentation) on medical product, or the side effect which is not specified in application instructions which directly or indirectly brought or could lead to death or serious aggravation of symptoms of health of users or the third parties (at the same time the serious aggravation of symptoms of health is understood as life-threatening disease, permanent defeat of function of organism or irreversible damage of structure of body, the condition requiring medical or surgical intervention for the purpose of prevention of life-threatening disease, either permanent defeat of function of organism, or irreversible damage of structure of body, the condition requiring hospitalization or significant increase in term of stay in hospital of already hospitalized patient functional violation at fruit, his death, congenital anomaly or birth trauma);

5) undesirable event - any undesirable medical event, not predicted disease either damage or undesirable clinical signs (including the laboratory indicators other than regulation) at users or the third parties connected using medical product;

6) the user - the patient, the medical specialist or any other physical person applying medical product to destination, determined by the producer of medical products;

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