After obtaining RZN certification for Class 2b medical devices, consider the following:

1. Post-Market Surveillance

• Monitoring and Reporting: Implement a post-market surveillance system to monitor the device's performance and safety once it is on the market. Report any adverse events or incidents to Roszdravnadzor as required.
• Customer Feedback: Collect and analyze feedback from users to identify any issues or improvements.

2. Compliance with Russian Regulations

• Ongoing Compliance: Ensure continuous compliance with Russian regulations and standards. Keep abreast

• of any updates or changes in the regulatory environment that might affect your device.

• Regulatory Changes: Stay informed about any amendments to regulations that may impact your device’s certification or market status.

3. Quality Management System (QMS)

• Maintenance: Maintain and regularly review your Quality Management System (QMS) to ensure it continues to meet the requirements of ISO 13485 and other applicable standards.
• Internal Audits: Conduct periodic internal audits to ensure ongoing adherence to quality management practices.

4. Renewal and Updates

• Certification Renewal: Monitor the validity period of your RZN certification and prepare for renewal before the certification expires.
• Product Changes: If there are significant changes to the device or its intended use, notify Roszdravnadzor and, if necessary, submit documentation for re-evaluation or an update to the certification.

5. Documentation and Records

• Maintain Records: Keep thorough records of all documentation related to the device, including the certification itself, technical files, post-market surveillance data, and any correspondence with Roszdravnadzor.
• Document Updates: Ensure that any updates to product documentation, labeling, or instructions for use are communicated to relevant stakeholders and are in compliance with Russian requirements.

6. Distribution and Market Access

• Distributor Requirements: Ensure that all distributors and importers comply with Russian regulations and understand the requirements for marketing and distributing your device in Russia.
• Labeling: Verify that product labeling remains compliant with Russian regulations, including translations and any additional requirements.

7. Training and Support

• Training: Provide training and support to healthcare professionals and users as needed to ensure safe and effective use of the device.
• Customer Service: Offer ongoing customer support to address any issues or questions that may arise post-certification.

8. Continuous Improvement

• Device Improvement: Use post-market data to identify opportunities for device improvements or modifications.
• Regulatory Updates: Regularly review and adapt to changes in regulatory standards and best practices.

Contact Us：

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