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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of June 9, 2022 No. KR DSM-50

About approval of Rules of issue of the expert opinion on compliance of characteristics of the technical specification for purchase of medical equipment

According to Item 153 of the order of the Government of the Republic of Kazakhstan of June 04, 2021 No. 375 "About approval of Rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance, pharmaceutical services", PRIKAZYVAYU:

1. Approve the enclosed Rules of issue of the expert opinion on compliance of characteristics of the technical specification for purchase of medical equipment.

2. To provide to department of medicinal policy 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 the 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 Legal department 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 supervising vice-Minister of Health of the Republic of Kazakhstan.

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

Minister of Health of the Republic of Kazakhstan

A. Giniyat

No. KR DSM-50 are approved by the Order of the Minister of Health of the Republic of Kazakhstan of June 9, 2022

Rules of issue of the expert opinion on compliance of characteristics of the technical specification for purchase of medical equipment

Chapter 1. General provisions

1. These rules of issue of the expert opinion on compliance of characteristics of the technical specification for purchase of medical equipment (further – Rules) are developed according to Item 153 of the order of the Government of the Republic of Kazakhstan of June 4, 2021 No. 375 "About approval of Rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance, pharmaceutical services".

2. The basic concepts used in these rules:

1) the state expert organization in the sphere of drug circulation and medical products – the subject of the state monopoly performing production economic activity in the field of health care on safety, efficiency and qualities of medicines and medical products (further – the expert organization);

2) the State register of medicines and medical products – the electronic information resource containing data about the medicines and medical products registered and allowed for medical application in the Republic of Kazakhstan;

3) medical equipment – the devices, devices, the equipment, complexes, systems applied separately or in combination among themselves to delivery of health care according to the functional purpose and operational characteristics established by the producer;

4) the applicant – physical person or legal entity, competent to submit applications, documents and materials for issue of the expert opinion for compliance of characteristics of the technical specification for purchase of medical equipment;

5) the expert opinion – the document, the issued expert organization according to these rules, for planning and the organization of purchase of medical equipment, used in case of delivery of health care within the guaranteed amount of free medical care (further – GOBMP) and (or) in system of compulsory social medical insurance (further – OSMS) (further – the conclusion).

Chapter 2. Procedure for issue of the expert opinion on compliance of characteristics of the technical specification for purchase of medical equipment

3. The conclusion is issued on the registered medical equipment for the organization of centralized purchase of medical equipment in case of delivery of health care within GOBMP and (or) in the OSMS system.

4. For issue of the conclusion by the expert organization the comparative analysis of functional parameters of the technical specification with technical characteristics at least two models of different producers of the medical equipment provided by the applicant is carried out.

5. For issue of the conclusion, the applicant provides in the expert organization:

1) the statement for issue of the conclusion on compliance of characteristics of the technical specification for purchase of medical equipment at least two models of different producers of medical equipment in form, according to appendix 1 to these rules;

2) the documents and materials containing data on technical characteristics of similar medical equipment in full accordance with data of the state register of medicines and medical products.

6. The expert organization performs issue of the conclusion following the results of the comparative analysis within 10 (ten) working days from the date of registration of a statement, in form according to appendix 2 to these rules.

In case of issue of the conclusion materials of the state register of medicines and medical products and documents of the corresponding registration file are considered.

7. In the presence of notes to the submitted documents according to item 4 of appendix 1 to these rules and (or) materials of the corresponding registration file, the expert organization sends to the applicant the answer (in any form) with indication of the revealed notes and need of their elimination in time which is not exceeding 7 (seven) working days from the moment of the direction of notes.

For the period of elimination of notes, terms of consideration of the application stop.

8. In case of not elimination by the applicant of notes the expert organization sends to the applicant the notification (in any form) about the termination of consideration of the application.

9. The applicant provides reliability, completeness and contents of the submitted documents according to the current legislation of the Republic of Kazakhstan and these rules.

Provision by the applicant of doubtful data is the basis for refusal in issue of the conclusion.

Effective period of the conclusion constitutes no more than 12 months from the date of its issue.

Appendix 1

to Rules of issue of the expert opinion on compliance of characteristics of the technical specification for purchase of medical equipment

Form

Name
expert organization
____________________________

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