Russia

Ministry of Health:     

Minzdrav

Regulatory Authority:          

Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Medical Device Regulation:          

Decree of the Government of the Russian Federation dated December 27, 2012 No. 1416

Official Language:      

Russian

Classification:    

Class I, IIa, IIb and III

Registration Process:

• Determine the device classification
• Appoint an Authorized Representative
• Prepare the Registration application form and Registration Dossier
• Submit the application to State Registration Authority
• The State authority shall notify the following:
• Document verification – 5 business days from the receipt date
• Start registration – 3 business days from receipt of completed application
• 30 days to submit the missing documents or complete detected violation
• The State Authority assign Expert Institution to carry out the quality, safety and efficacy examination of the medical device
• The manufacturer may now begin clinical trial after notification to the State Authority
• Once the Conformity Assessment and Clinical trial report is approved, the State Authority shall enter the data into the state registry
• The medical device can now be marketed in Russia