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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of November 30, 2021 No. 2129

About approval of the Regulations on licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application), modification of the Order of the Government of the Russian Federation of September 15, 2020 No. 1445 and recognition voided separate acts of the Government of the Russian Federation

According to the Federal Law "About Licensing of Separate Types of Activity" Government of the Russian Federation decides:

1. Approve enclosed:

Regulations on licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application);

changes which are made to the order of the Government of the Russian Federation of September 15, 2020 No. 1445 "About approval 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" (The Russian Federation Code, 2020, No. 39, Art. 6037; No. 49, Art. 7934).

2. Assessment of conformity of the licensee to licensed requirements according to the Provision approved by this resolution is carried out in connection with change of the list of works, services which are performed as a part of the licensed type of activity.

The legal entities, individual entrepreneurs having license for activities on production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment, with indication of works, services which are carried out regarding maintenance of medical equipment during the period shall give from March 1, 2022 to January 1, 2024 to the Federal Service on supervision in the field of health care of the statement for modification of the register of licenses in connection with change of the list of the performed works, the rendered services as a part of the licensed type of activity according to the procedure, the stipulated in Clause 18 Federal Laws "About Licensing of Separate Types of Activity" (in edition of the Federal Law "About modification of separate legal acts of the Russian Federation in connection with adoption of the Federal Law "About the State Control (Supervision) and Municipal Control in the Russian Federation").

3. To the Federal Service on supervision in the field of health care till September 1, 2022 to staticize data of register entries of the unified register of the licenses containing data on maintenance of medical products which according to the Provision approved by this resolution does not require receipt of the license.

4. Recognize voided since March 1, 2022:

the order of the Government of the Russian Federation of September 15, 2020 No. 1445 "About approval 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" (The Russian Federation Code, 2020, No. 39, the Art. 6037);

Item of 5 changes which are made to acts of the Government of the Russian Federation concerning licensing of the separate types of activity approved by the order of the Government of the Russian Federation of November 28, 2020 No. 1961 "About introduction of amendments to some acts of the Government of the Russian Federation concerning licensing of separate types of activity" (The Russian Federation Code, 2020, No. 49, the Art. 7934).

5. The provision approved by this resolution becomes effective since March 1, 2022 and is effective till March 1, 2028.

The changes approved by this resolution become effective since January 1, 2022 and are effective till March 1, 2022.

 Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of November 30, 2021 No. 2129

Regulations on licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application)

1. This Provision determines procedure for licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application) (further - activities for maintenance of medical products).

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