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Ministry of Justice

Russian Federation

On February 1, 2021 No. 62308

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

of November 19, 2020 No. 10826

About approval of Administrative regulations of the Federal Service on supervision in health sector on implementation of licensed control of activities for production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment

According to Item 14 of the Regulations on licensing of activities for production and maintenance (except for case, if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment approved by the order of the Government of the Russian Federation of September 15, 2020 No. 1445 (The Russian Federation Code, 2020, No. 39, the Art. 6037), and the order of the Government of the Russian Federation of May 16, 2011 No. 373 "About development and approval of administrative regulations of implementation of the state control (supervision) and administrative regulations of provision of the state services" (The Russian Federation Code, 2011, No. 22, Art. 3169; 2018, 46, of the Art. 7050) I order to No.:

Approve the enclosed Administrative regulations of the Federal Service on supervision in health sector on implementation of licensed control of activities for production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment.

Head

A. V. Samoylova

Approved by the Order of the Federal Service of the Russian Federation on supervision in health sector of November 19, 2020, No. 10826

Administrative regulations of the Federal Service on supervision in health sector on implementation of licensed control of activities for production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment

I. General provisions

1. The administrative regulations of the Federal Service on supervision in health sector (further - Administrative regulations) on implementation of licensed control of activities for production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment establish terms and the sequence of ministerial procedures (actions), order of interaction between structural divisions of Roszdravnadzor in case of execution of the state function.

Name of function

2. The state function regulated by Administrative regulations is implementation of licensed control of activities for production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment (further respectively - licensed control, the state control (supervision).

The name of the body exercising the state control (supervision)

3. Licensed control is exercised by the Federal Service on supervision in health sector (further - Roszdravnadzor).

The regulatory legal acts regulating implementation of the state control (supervision)

4. The list of the regulatory legal acts (with indication of their details and sources of official publication) regulating implementation of licensed control is posted on the official site of Roszdravnadzor on the Internet (further - the official site of Roszdravnadzor), in the federal state information system "Federal Register of the State Services (Functions)" (further - the Federal register) and in the federal state information system "Single Portal of the State and Municipal Services (Functions)" (further - the Single portal).

Subject of the state control (supervision)

5. Subject of licensed control is the organization and conducting checks of observance by licensees of the licensed requirements when implementing activities for production and maintenance (except for case, if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment established by the Regulations on licensing of activities for production and maintenance (except for case, if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment (further - licensed requirements, regulations on licensing) approved by the order of the Government of the Russian Federation of September 15, 2020 No. 1445 <1>.

--------------------------------

<1> Russian Federation Code, 2020, No. 39, Art. 6037.

The rights and obligations of officials when implementing the state control (supervision)

6. The rights of officials of Roszdravnadzor when implementing licensed control:

1) to consider documents and the materials characterizing check subject;

2) when conducting exit check freely to get access to the territory, to the buildings used by the licensee when implementing activities, structures, constructions and rooms, to the equipment used by the licensee, subsidiary objects and vehicles;

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