1. Annual Review

• Medical device registrations may require annual reviews to ensure that the manufacturer continues to comply with regulatory standards and maintains a robust Quality Management System (QMS).

2. Changes in Product Specifications

• If there are any changes to the product design, manufacturing processes, or labeling, manufacturers must notify the NMPA and submit updated documentation. Significant changes may require a new application or re-evaluation.

3. Post-Market Surveillance Reporting

• Manufacturers must establish and maintain a post-market surveillance system to monitor the safety and efficacy of their devices. Adverse events must be reported to the NMPA, and any necessary corrective actions should be documented and communicated.

4. Renewal of Registration

• Medical device registrations typically have a validity period (often five years). Manufacturers must apply for renewal before the expiration date, providing updated information and compliance documentation.

5. Compliance with New Regulations

• As regulations evolve, manufacturers must stay informed about any changes in NMPA requirements that may affect their devices. This could include updates to safety standards, testing requirements, or registration processes.

6. Inspection Readiness

• Regular internal audits and compliance checks help ensure that the manufacturer is prepared for any NMPA inspections that may occur throughout the registration period.

Conclusion

To maintain the validity of their medical device registrations in China, manufacturers must actively manage compliance and update their registrations as needed. This proactive approach helps prevent issues and ensures that devices remain safe and effective in the market.

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