THE ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION AND THE FEDERAL SERVICE OF THE RUSSIAN FEDERATION ON SUPERVISION IN THE FIELD OF HEALTH CARE

of August 19, 2026 No. 750

About approval of Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service "State Registration of Medical Products"

According to Item 3 of Rules of state registration of the medical products approved by the order of the Government of the Russian Federation of November 30, 2024 No. 1684, subitem 5.5 of Item 5 of the Regulations on the Federal Service on supervision in the field of the health care approved by the order of the Government of the Russian Federation of June 30, 2004 No. 323, Item 2 of Rules of development and approval of administrative regulations of provision of the state services approved by the order of the Government of the Russian Federation of July 20, 2021 No. 1228, Item 2 of the order of the Government of the Russian Federation of October 14, 2023 No. 1706 "About features of development, approval, conducting examination and approval of administrative regulations of provision of the state services in 2024 - 2026 including without use of federal state information system providing maintaining the federal register of the state services" I order:

1. Approve the enclosed Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service "State Registration of Medical Products".

2. Declare invalid the order of the Federal Service on supervision in the field of health care of May 6, 2019 No. 3371 "About approval of administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service in state registration of medical products" (registration No. 55388) is registered by the Ministry of Justice of the Russian Federation on July 25, 2019.

3. This order is effective till December 31, 2028.

Approved by the Order of the Federal Service of the Russian Federation on supervision in the field of health care of August 19, 2026 , No. 750

Administrative regulations of the Federal Service on supervision in the field of health care on provision of the state service "State Registration of Medical Products"

I. General provisions

1. These Administrative regulations establish procedure and the standard of provision of the state service "State Registration of Medical Products".

2. The service (the list of symbols and reducings is given in appendix to these Administrative regulations) is provided to producers (manufacturer) of medical products or to their authorized representatives.

3. The service is provided to the applicant according to categories (signs) of applicants, data on which are placed in the federal state information system "Federal Register of the State and Municipal Services" <1> and on the Single portal <2>.

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<1> Item 1 of the Regulations on the federal state information system "Federal Register of the State and Municipal Services (Functions)" approved by the order of the Government of the Russian Federation of October 24, 2011 No. 861.

<2> Item 1 of the Regulations on the federal state information system "Single Portal of the State and Municipal Services (Functions)" approved by the order of the Government of the Russian Federation of October 24, 2011 No. 861.

II. Standard of provision of Service

Name of Service

4. State registration of medical products.

The name of the body providing Service

5. The service is provided by the Federal Service on supervision in the field of health care.

Result of provision of Service

6. In case of the address of the applicant according to the table No. 1, containing in appendix to these Administrative regulations, behind state registration of medical products which confirmation of efficiency requires carrying out clinical testing with participation of the person and receipt of permission of Authority to carrying out clinical testing the register entry entered in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products is result of provision of Service.

7. In case of the address of the applicant according to the table No. 1, containing in appendix to these Administrative regulations, behind state registration of medical products which confirmation of efficiency does not require carrying out clinical testing with participation of the person and receipt of permission of Authority to carrying out such clinical testing the register entry entered in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products is result of provision of Service.

8. In case of the address of the applicant according to the table No. 1, containing in appendix to these Administrative regulations, behind state registration of domestic medical products, the register entry entered in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products is result of provision of Service.

9. In case of the address of the applicant according to the table No. 1, containing in appendix to these Administrative regulations, behind modification of the documents containing in the registration file, not requiring conducting examination of quality, efficiency and safety of medical product, modification of the register entry in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products is result of provision of Service.

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