For periodic updates of RZN certification for Class I medical devices, follow these standards and procedures:

1. Monitor Regulatory Changes: Stay informed about any changes in Russian regulations or standards that might affect your device's certification.

2. Prepare Documentation: Update your technical documentation to reflect any changes in device design, manufacturing processes, or safety information.

3. Submit Renewal Application: Before the certification expires, submit a renewal application to Roszdravnadzor. This may involve resubmitting updated documents and evidence of continued compliance.

4. Quality Management System Review: Ensure your quality management system remains compliant with ISO 13485 and any additional requirements set by Roszdravnadzor.

5. Conduct Post-Market Surveillance: Provide evidence of ongoing post-market surveillance activities, including any reports of adverse events or device performance issues.

6. Update Labeling and Packaging: Ensure that your device’s labeling and packaging are up-to-date and comply with current regulatory requirements.

7. Contact Us：

8. Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn

9. Inspection and Testing: Be prepared for any additional inspections or testing that may be required as part of the renewal process.

Adhering to these procedures ensures that your device remains compliant and that the certification is kept current.