of March 18, 2020 No. 299
About modification of Rules of state registration of medical products
The government of the Russian Federation decides:
1. Approve the enclosed changes which are made to the Rules of state registration of medical products approved by the order of the Government of the Russian Federation of December 27, 2012 No. 1416 "About approval of Rules of state registration of medical products" (The Russian Federation Code, 2013, No. 1, Art. 14; No. 43, Art. 5556; 2014, No. 30, Art. 4310; 2017, No. 8, Art. 1233; 2018, No. 24, Art. 3523).
2. This resolution becomes effective from the date of its official publication.
Russian Prime Minister
M. Mishustin
Approved by the Order of the Government of the Russian Federation of March 18, 2020 No. 299
1. To add Item 5 after paragraph one with the paragraph of the following content:
"Features of state registration of medical products with low degree of potential risk of their application concerning which features of state registration are established according to the list according to appendix (further - the list) are provided by Items 57 - 57(20) these rules.".
2. Item 8 and paragraph one of Item 10 after the words "For State Registration of Medical Product" to add with words "(except for the medical products included in the list)".
3. The paragraph one of Item 19 after the words "State Registration of Medical Products" to add with words "(except for the medical products included in the list)".
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The document ceased to be valid since March 1, 2025 according to item 4 of the Order of the Government of the Russian Federation of November 30, 2024 No. 1684