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:
Russian
Classification:
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:
Yes
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