ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of September 6, 2019 No. KR DSM-124

About approval of Rules of carrying out technical testing of medical products

According to Item 3 of article 73 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve the enclosed Rules of carrying out technical testing of medical products.

2. To provide to committee of quality control and safety of goods and services of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

3) within ten working days after state registration of this order submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

3. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Nadyrov K. T.

4. This order becomes effective after ten calendar days after day of its first official publication.

No. KR DSM-124 are approved by the Order of the Minister of Health of the Republic of Kazakhstan of September 6, 2019

Rules of carrying out technical testing of medical products

Chapter 1. General provisions

1. These rules of carrying out technical testing (further - Rules) are developed according to Item 3 of article 73 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" and determine procedure for carrying out technical testing of medical products.

2. Technical testing of medical products are carried out in the form of testing and (or) assessment and data analysis for quality check and safety in case of their use according to the appointment provided by documentation of the producer of medical product.

Chapter 2. Procedure for carrying out technical testing of medical products

3. For carrying out technical testing the producer of medical product or its authorized representative provides in test laboratory:

1) the statement on carrying out technical testing of medical products in form according to appendix 1 to these rules;

2) regulating documents on medical products with indication of the list of standards to which there correspond medical products;

3) technical and operational documentation on medical product (working drawings, tables and schemes, technical regulating documents for statement of products on production);

4) the program of technical testing of medical product developed by the applicant;

5) copies of protocols of technical testing of medical product (in the presence);

6) data on marking and packaging of medical product;

7) samples of medical products.

4. Technical testing of medical product include:

1) the analysis of regulating, technical and operational documentation on medical product, programs of technical testing, and also protocols of earlier carried out testing and decision making about carrying out technical testing;

2) sampling and identification of medical product;

3) carrying out technical testing of medical product according to the program of technical testing of medical product, the developed applicant;

4) registration and issue to the applicant of the protocol of technical testing of medical product.

5. The test laboratory within 10 calendar days from the date of filing of application on carrying out technical testing of medical product carries out the analysis of the documents submitted by the applicant.

In case of decision making about carrying out technical testing of medical product the test laboratory signs the relevant contract with the applicant according to the Civil code of the Republic of Kazakhstan of December 27, 1994.

In case of impossibility of carrying out technical testing of medical product, the test laboratory in written (any) form notifies the applicant on refusal in carrying out technical testing of medical product (with indication of the reasons).

6. Technical testing of medical products are carried out on the samples of medical product provided by the applicant.

Sampling of medical product is performed by the applicant or according to its order test laboratory in the presence of the applicant.

If sampling of medical product is performed by the applicant, this information is specified in the statement.

If sampling of medical product is performed by test laboratory at the request of the applicant, results of selection are drawn up by the sampling report of medical product in form according to appendix 2 to these rules.

At all stages of storage, transportation and preparation for technical testing of the selected samples of medical product the conditions established in regulating, technical or operational documentation on medical product are complied.

7. Technical testing are not performed concerning medical products for diagnostics of invitro (invitro) - (reagents, sets of reagents).

8. In the course of technical testing of samples of medical product the test laboratory estimates:

1) compliance of medical product to the parameters provided in regulating, technical or operational documentation;

2) completeness and objectivity of the characteristics established by the regulating documentation which are subject to control in case of release of medical products and also frequency, plans of control and its methods;

3) design and operability of medical products from the point of view of safety, convenience of use, operational and ergonomic indicators;

4) marking and packaging of medical product.

9. In the presence of group of uniform medical products carrying out technical testing on standard samples of the medical products made according to one regulating document and on single technology is allowed.

At the same time selection of standard samples on structure of medical products reflects all set of group of uniform medical products taking into account distinction of properties of separate types of medical products (brands, models) in this set.

In case of carrying out technical testing on standard samples in the protocol of technical testing it is specified about distribution of results of technical testing of standard samples for certain group of uniform medical products.

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