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New procedure on medical devices import for their further registration


 
 
According to the new procedure, Roszdravnazor (Russian Federal Service for Surveillance in Healthcare) issues an authorization for medical device import for its further registration in electronic format. Such authorization is valid within 1 year and allows the applicant to import a medical device once. 
 
Authorization is to be issued upon application in electronic format in the name of the medical device manufacturer or its representative in Russia. The application may be filed by using the respective service on the Roszdravnadzor official website. Copies of agreements on corresponding trials (studies) shall be filed along with the application. The applicant determines the number of medical device samples on recommendation of companies leading trials depending on potential risk class and scope of expected trials (studies).
 
Roszdravnadzor shall decide within 5 working days whether to issue the import authorization or reject its issuance. The Roszdravnadzor decision is to be published on the official website within 2 working days.
 
The procedure introduces an exhaustive list of grounds for rejection to issue the authorization. For instance, a rejection may be caused by non-providing or incomplete providing Roszdravnadzor with the requested information and documentation, import restrictions, or non-indicated side effects in a product instruction.
 
Upon the applicant’s application, the authorization may be annulled.
 
Software as a medical device does not require such import authorization.
 
Unlike the previous procedure2 the new one allows 1-year instead of 6-months validity of import authorization, and more grounds for rejection of authorization issuance. 
 
_____
1Russian Minzdrav Ruling No. 661n dated 30 June 2020, registered by Russian Minjust under No. 60070 dated 28 September 2020
2Russian Minzdrav Ruling No. 7n dated 15 June 2012, registered by Russian Minjust under No. 25013 dated 15 July 2012
 


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