ll required documentation, including:

• Application Form for medical device registration.
• Description of the Device: Technical details, intended use, and the device’s composition.
• Clinical Trial Data: If applicable, provide clinical data supporting the device’s safety and efficacy.
• Manufacturing Documentation: Evidence of the manufacturer’s compliance with Good Manufacturing Practices (GMP).
• Risk Analysis: Conduct a risk assessment of the device (e.g., Failure Modes and Effects Analysis, or FMEA).
• CE Mark (if applicable): If the device is already marketed in the EU, provide the CE certification as part of the evidence of safety.
• Instructions for Use and labeling materials in Russian.

3. Submit an Application to the Russian Ministry of Health (RZN)

The application is submitted to the Federal Service for Surveillance in Healthcare (Roszdravnadzor), which is the regulatory body responsible for medical device registration in Russia.

• Online Submission: The application and documents are generally submitted electronically through the Ministry's portal or an authorized representative.
• Authorized Representative: If you are not based in Russia, you will need to appoint a local representative to handle the registration process on your behalf.

4. Technical Expertise Evaluation

The RZN may request a technical review of the device's documentation. In some cases, they may require the device to undergo additional testing or verification to confirm its compliance with Russian standards (GOST-R or other relevant standards).

5. Pre-Registration Inspection (if applicable)

Although not always required for Class 3 devices, in some cases, an on-site inspection of the manufacturing facility may be requested. This can be part of the evaluation process, especially for high-risk devices.

6. Review and Approval

The RZN will review your submission, and if all the requirements are met, they will approve the registration and issue a certificate. This process typically takes 6-12 months for Class 3 devices due to their complexity.

7. Post-Market Surveillance and Reporting

After registration, you must comply with post-market surveillance requirements, which may include periodic safety reports, adverse event reporting, and any updates to the device documentation.

Additional Considerations:

• Language: All documentation must be in Russian or translated into Russian.
• Local Representation: It is mandatory for foreign manufacturers to have a local authorized representative in Russia who can interact with the regulatory authorities.
• Registration Fees: Fees for registration may apply, and these can vary depending on the class of the device and the complexity of the submission.

This process can be complex, so it is highly recommended to work with a local regulatory consultant or an authorized representative to navigate the requirements and expedite the process.

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