To apply for 3rd class medical device registration in Russia, the process is managed through Roszdravnadzor (the Russian Federal Service for Surveillance in Healthcare), the regulatory authority responsible for overseeing medical devices and pharmaceuticals in Russia.

Where to Apply:

You can submit your application for 3rd class medical device registration through Roszdravnadzor either online or in person, depending on the process specified. Here’s how you can proceed:

1. Roszdravnadzor’s Online Portal (for Electronic Submission)

• Official Website: The Roszdravnadzor website provides an online system for registering medical devices. The online submission process is mandatory for all applications.

  Website: Roszdravnadzor Official Website

• Online Registration Portal:

  • Access the online portal for submission: Roszdravnadzor E-Services Portal.
  • The portal allows users to submit applications, track the status of their submissions, and communicate with Roszdravnadzor regarding any necessary updates.

• Account Setup: To use the portal, you must create an account and have access to submit documents electronically. This includes creating a personal or company profile and filling out the required application forms.

2. Authorized Representative Submission

• For Foreign Manufacturers:

  • If you are a foreign manufacturer, you must appoint a local authorized representative in Russia to submit the application on your behalf. This representative is responsible for all communication with Roszdravnadzor and ensuring that all documentation is compliant with Russian regulations.

  • The authorized representative can submit the application through the online portal on your behalf, but the process remains the same.

3. Roszdravnadzor Offices (Offline Submission)

• For Specific Cases: In some instances, if electronic submission is not possible or if additional documentation needs to be submitted physically, you may need to visit the Roszdravnadzor offices.

  • Address for Submission:
    • Roszdravnadzor Headquarters:
      11/9, Ryazanskiy Prospekt, Moscow, Russia.
      • Contact Information: You can reach out to Roszdravnadzor via email or phone for guidance on any offline submission requirements or specific queries.
      • Phone: +7 (495) 627-98-30
      • Email: info@roszdravnadzor.ru (or specific department emails).

4. Submission Process and Key Steps

• Step 1: Prepare Documentation:

  • Prepare all necessary documents such as technical files, clinical data, risk assessments, translations of labels/instructions into Russian, and certificates.

• Step 2: Submit Online or via Representative:

  • Your authorized representative (if you’re a foreign manufacturer) will submit the application online.
  • Foreign manufacturers must ensure that all documents are translated into Russian and are compliant with Russian technical and medical standards.

• Step 3: Payment of Fees:

  • Pay the required registration fees as specified by Roszdravnadzor.

• Step 4: Application Review:

  • Roszdravnadzor will process the application, and you may need to provide additional documents or information as part of the review process.

Additional Notes:

• Language Requirement: All documents submitted to Roszdravnadzor, including technical files, clinical data, and instructions for use, must be translated into Russian.
• Expert and Technical Review: For Class 3 devices, Roszdravnadzor typically requires a technical review and clinical evaluation, which can take several months to complete.
• Local Representation: It’s essential to have a local representative, as foreign manufacturers cannot directly interact with Roszdravnadzor for registration purposes.

Conclusion

To apply for 3rd class medical device registration in Russia, you must go through the Roszdravnadzor website and the online submission portal. Foreign manufacturers are required to appoint a local authorized representative in Russia, who will handle the submission on their behalf. The process involves careful documentation, translations, and compliance with Russian regulatory standards.

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