of December 25, 2023 No. 2288
About modification of the Order of the Government of the Russian Federation of November 30, 2021 No. 2129
The government of the Russian Federation decides:
1. Item 3 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) approved by the 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" (The Russian Federation Code, 2021, No. 49, Art. 8315; 2023, No. 34, of the Art. 6581) to add with the paragraph of the following content:
"Under condition if the producer of medical products or the authorized representative of the producer of medical products of foreign production, data on which contain in the registration file on medical product, performs maintenance only of the medical products made by it, action of the paragraph of the third subitem "an" and paragraph of the third subitem "b" of Item 5, of the subitem "b" of Item 9, of the paragraph of the fourth subitem "an" and the paragraph of the third subitem "b" of Item 10 and the subitem "b" of Item 14 of this provision does not extend to it.".
2. This resolution becomes effective from the date of its official publication.
Russian Prime Minister
M. Mishustin
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