Medical Device Registration Russia

Ministry of Health:     


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:      



Class I, IIa, IIb and III

Medical Device Registration in Russia:

  • 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

Documents Required:          

  • Registration Application
  • Letter of Authorization for Authorized Representative
  • Information on normative documentation for medical device
  • Technical documentation
  • User manuals, IFUs, Artwork
  • Technical drawing
  • Technical Trial report & its finding
  • Toxicology study reports
  • Summary of list of documents attached
  • Clinical effectiveness and safety reports (if applicable)
  • Draft plan of Clinical trials

Post-market surveillance:  

Russian Federation dated October 19, 2020 No. 1113

Applicable QMS:          

Decree of the Government of the Russian Federation dated February 09, 2022 No. 135

Registration Timeline:         

50 days*

*Does not include the time required for clinical trials

Authorized Representative:          


License Validity:          

Does not expire

Special Notes:    

  • All documents must be submitted in the Russian language.
  • Clinical Trials of the medical device shall be conducted as part of the conformity assessment, on approval with MoH procedure

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