ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 1, 2020 No. 1335

About modification of Item 2 of Rules of state registration of medical products

The government of the Russian Federation decides:

1. State paragraph two of Item 2 of Rules of state registration of the 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; 2014, No. 30, the Art. 4310), in the following edition:

"The medical products listed in Item 11 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014 including medical products which are made by individual orders of patients to which special requirements to destination of health workers are imposed and which are intended only for personal use by the specific patient and also medical products which are held for use in the territory of the international medical cluster or in the territories of the innovative scientific and technological centers are not subject to state registration according to part 5 of article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation".".

2. This resolution becomes effective since September 1, 2020.

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