To obtain Class III medical device RZN certification in Russia, follow these procedures and steps:

1. Pre-Application Preparation:

   • Research: Understand the Russian medical device regulations and specific requirements for Class III devices.
   • Documentation: Gather essential documents such as product specifications, clinical trial data, and manufacturing quality management systems.

2. Choose a Notified Body:

   • Accredited Body: Select an accredited certification body authorized by Roszdravnadzor to handle Class III medical devices.

3. Submit Application:

   • Application Form: Complete and submit the application form to the chosen certification body.
   • Documentation: Provide comprehensive documentation including:
     • Device description and intended use
     • Clinical evidence and risk assessment
     • Quality management system documentation
     • Manufacturing process details

4. Technical Evaluation:

   • Review: The certification body reviews the submitted documentation for compliance with Russian standards.
   • Testing: If necessary, conduct additional testing or provide further evidence as requested.

5. On-Site Inspection:

   • Facility Audit: The certification body may conduct an on-site inspection of your manufacturing facility to ensure compliance with Russian standards and Good Manufacturing Practices (GMP).

6. Certification Decision:

   • Assessment: After evaluating all documentation and inspection results, the certification body makes a decision.
   • Issuance: If approved, you receive the RZN certificate, allowing you to market the device in Russia.

7. Post-Certification Compliance:

   • Ongoing Monitoring: Maintain compliance with Russian regulations and be prepared for periodic audits and inspections.

8. Update Documentation:

   • Amendments: Notify Roszdravnadzor of any significant changes to the device or its manufacturing process.

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