Yes, medical devices in China require regular updates for their registration, particularly under the NMPA (National Medical Products Administration) regulations. Here are the key points regarding the need for updates:

1. Periodic Review

• Medical device registrations may be subject to periodic reviews by the NMPA. This ensures that products continue to meet safety and efficacy standards over time.

2. Post-Market Surveillance

• Manufacturers must engage in post-market surveillance, monitoring the performance of their devices once they are on the market. If issues arise (such as adverse events or product recalls), manufacturers are required to report these to the NMPA and may need to update their registration.

3. Changes to the Device

• Any significant changes to the device, such as modifications in design, manufacturing processes, or intended use, require an update to the registration. The NMPA may classify these changes as minor or major, determining the extent of documentation needed for the update.

4. Quality Management System Updates

• If there are updates or changes to the manufacturer’s quality management system (QMS) or compliance status (e.g., changes in ISO certifications), these may also necessitate an update in the registration.

5. Regulatory Changes

• Manufacturers must stay informed about any changes in regulations or standards that affect their devices. Compliance with new guidelines may require updates to the registration.

6. Renewal Requirements

• The NMPA registration typically has a validity period (often five years). Manufacturers must apply for renewal before the expiration date, providing updated documentation and information.

Conclusion

Regular updates and compliance with evolving regulations are essential for maintaining medical device registration in China. Manufacturers should have a proactive approach to monitor their products and the regulatory landscape to ensure ongoing compliance.