For RZN certification of Class C medical devices, an annual review is not typically required. However, there are several important considerations and requirements for maintaining certification:

1. Periodic Compliance Checks

• Regulatory Updates: While an annual review specifically is not mandated, your device must remain compliant with any changes in Russian regulations and standards. This involves staying updated on regulatory changes and ensuring ongoing adherence to current requirements.

2. Post-Market Surveillance

• Ongoing Monitoring: You are required to monitor the performance of your device once it is on the market. This includes tracking any adverse events or issues that arise and reporting them to RZN as necessary.
• Updates and Reports: Submit any required periodic reports or updates about the device’s performance, safety, and any post-market issues to RZN.

3. Certification Validity and Renewal

• Certification Duration: RZN certification for Class C medical devices is typically valid for five years.
• Renewal Process: Before the certification expires, you must initiate the renewal process. This may involve updating documentation, submitting new data, and possibly undergoing another review or inspection.

4. Quality Management System (QMS) Maintenance

• Ongoing Compliance: Maintain a Quality Management System (QMS) that complies with ISO 13485 or an equivalent standard. Regular audits and updates to your QMS are essential for ensuring ongoing compliance with regulatory requirements.

5. Additional Requirements

• Additional Inspections: If there are significant changes to the device or manufacturing process, or if RZN deems it necessary, additional inspections or reviews may be required.

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