For the periodic review of RZN certification for Class C medical devices, it's crucial to stay updated with the relevant standards and processes to ensure ongoing compliance. Here are the key aspects to consider:

1. Updated Standards

• TR CU 020/2011: This Technical Regulation of the Customs Union outlines safety and performance requirements for medical devices. Ensure compliance with any amendments or updates to this regulation.
• ISO 13485:2016: Maintain compliance with this quality management standard, which is essential for ongoing certification and periodic reviews.
• ISO 14971:2019: Adhere to updated guidelines for risk management and ensure that your risk management processes are current and effective.
• IEC 60601 Series: For electrical medical devices, ensure compliance with updated versions of these standards, particularly concerning safety and performance.
• GOST R Standards: Keep up-to-date with any changes in GOST R standards applicable to medical devices.

2. Periodic Review Processes

• Review Schedule: RZN certification typically requires periodic reviews to ensure ongoing compliance. Be aware of the certification validity period (often 5 years) and initiate the review process before the expiration.
• Document Updates: Regularly update your technical documentation, including clinical data, risk management reports, and quality system records, to reflect any changes or new requirements.
• Internal Audits: Conduct internal audits to assess compliance with your quality management system and the latest regulatory requirements. Address any findings or non-conformities.
• Quality Management System Review: Periodically review and update your quality management system (QMS) to ensure it remains effective and compliant with ISO 13485 and other relevant standards.
• Regulatory Changes: Stay informed about any changes in regulations or standards that could impact your device and incorporate these changes into your compliance processes.

3. Submitting Updates and Information

• Notify RZN: Inform RZN of any significant changes to your device, manufacturing processes, or quality management system. This includes updates to technical documentation, device modifications, or changes in risk management practices.
• Renewal Application: Prepare and submit a renewal application before the certification expires. Include updated documentation and any new information required by RZN.

4. Continuous Improvement

• Feedback Incorporation: Use feedback from market surveillance, user complaints, and post-market monitoring to improve your device and address any issues promptly.
• Corrective Actions: Implement corrective and preventive actions based on findings from audits, inspections, and post-market data.

5. Authorized Representative

• Maintain Local Representation: Ensure that your authorized representative in Russia is informed about any changes and continues to handle regulatory affairs effectively.

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