For Class III medical device RZN certification in Russia, there is no specific annual review requirement like those found in some other regulatory systems. However, there are several ongoing obligations and considerations to ensure continued compliance:

1. Post-Market Surveillance

a. Continuous Monitoring

• Performance Tracking: Manufacturers must implement a system to monitor the device’s performance in the market, including tracking adverse events and safety issues.
• Reporting: Adverse events or incidents must be reported to Roszdravnadzor as per regulatory requirements.

2. Certification Renewal

a. Renewal Period

• Validity Duration: The RZN certification for Class III medical devices is typically valid for 5 years. Manufacturers must apply for renewal before the certification expires.

b. Renewal Process

• Reevaluation: The renewal process involves submitting updated documentation and possibly undergoing a new review to ensure ongoing compliance with regulatory standards.
• Inspection: A new facility inspection may be required depending on the regulatory changes and updates.

3. Regulatory Updates

a. Compliance with Changes

• Regulation Updates: Manufacturers must stay informed about any changes in Russian regulations or standards and ensure that their devices continue to comply with new requirements.
• Documentation Updates: Regular updates to documentation, labeling, and instructions for use (IFU) may be necessary to reflect changes in regulations or device modifications.

4. Quality Management System

a. Ongoing Compliance

• QMS Maintenance: The manufacturer must maintain compliance with quality management system standards like ISO 13485 throughout the certification period.
• Internal Audits: Regular internal audits and management reviews should be conducted to ensure the ongoing effectiveness of the QMS.