Yes, NMPA-registered medical devices in China generally need to be updated regularly to ensure compliance with the latest regulations and standards. Here are a few key points regarding the update requirements:

1. Registration Renewal

• Frequency: Medical device registrations are valid for five years. Manufacturers must apply for registration renewal before the expiration date to keep their product on the market.

2. Updates Due to Changes

• Significant Changes: If there are significant changes to the device—such as modifications to its design, intended use, manufacturing processes, or labeling—manufacturers are required to submit a supplementary application. This applies regardless of the class of the device.

• Examples of Changes: Changes that trigger a need for updates include new indications, changes in manufacturing location, changes in the specifications of the device, and any alterations that may affect its safety or efficacy.

3. Post-Market Surveillance

• Ongoing Obligations: Manufacturers are required to implement post-market surveillance systems to monitor the safety and effectiveness of their devices once they are on the market. Any adverse events must be reported to the NMPA within 15 days.

• Updates Based on Surveillance Findings: If post-market surveillance generates new safety data or insights about the product, manufacturers may need to update their registration or product information accordingly.

4. Regulatory Changes

• Compliance with New Regulations: The NMPA periodically updates its regulations and standards. Manufacturers must ensure that their devices comply with any newly introduced regulations, which may require updates to documentation, processes, or even product features.

5. Documentation and Quality Management System

• Continuous Updates: The technical documentation and the quality management system must be kept current. This includes updating risk management files, clinical evaluation reports, and product specifications to reflect any changes in the product or regulatory requirements.

Conclusion

Regular updates to NMPA-registered medical devices are essential to ensure ongoing compliance and product safety. Manufacturers should have processes in place to monitor regulatory changes, manage post-market surveillance, and respond promptly to any changes or findings that necessitate updates.

If you have specific scenarios or types of devices in mind regarding update requirements, feel free to share!

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