Roszdravnadzor informs about the entry into force of the Regulation on the commission of Roszdravnadzor on the formation of a list of alcohol-containing medical devices
The Federal Service for Supervision of Healthcare informs that from February 9, 2020, Roszdravnadzor Order No. 7975 of October 23, 2019 “On approval of the Regulation on the Commission of the Federal Service for Supervision of Healthcare on the formation of a list of alcohol-containing medical devices for production activities , the manufacture and (or) turnover of which is not covered by the Federal Law “On State Regulation of the Production and Turnover of Ethyl Alcohol, Alcoholic and Alcohol-Containing Products, and boundedness consumption (drinking) alcohol products “(Registered in the Ministry of Justice of Russia 28/1/2020 number 57 291) (hereinafter – the Regulations, List).
The publication of this order is aimed at fulfilling the requirements of paragraph 2 of the Government of the Russian Federation dated June 15, 2019 No. 774 “On approval of the Rules for the formation of a list of alcohol-containing medical devices, the production, manufacture and (or) turnover of which is not covered by the Federal Law“ On state regulation of the production and turnover of ethyl alcohol, alcoholic and alcohol-containing products and the restriction of consumption (drinking) of alcoholic products ”(hereinafter – the Rules) in parts of the approval of the Regulation on the commission of Roszdravnadzor on the formation of the specified List (hereinafter – the Commission).
Please note that in accordance with paragraph 7 of the Rules, the List is compiled on the basis of proposals submitted by Roszdravnadzor to manufacturers (manufacturers) or authorized representatives of the manufacturer (manufacturer) of the corresponding medical device to include the medical device in the List (exclusion from the List) (hereinafter – the Proposals) in the period from January 1 to June 30 inclusive.