Yes, medical devices in China need to undergo regular reviews and updates to maintain their NMPA (National Medical Products Administration) registration. The review process is a crucial part of ensuring ongoing compliance with the latest regulations, standards, and safety requirements throughout the product's lifecycle. Below are the key elements related to the regular review of medical device registration in China:

1. Annual Registration Renewal

For certain classes of medical devices, particularly Class II and Class III devices, manufacturers are required to submit annual registration renewal documents to the NMPA to ensure continued compliance with regulatory requirements.

• Class II and III devices must undergo an annual review to maintain their market authorization. The manufacturer may need to provide updated documentation related to product performance, safety, and adverse event reporting.
• Class I devices are generally exempt from this annual renewal but may still require periodic updates or checks based on specific regulatory changes.

2. Post-Market Surveillance and Reporting

Once a medical device is registered in China, it falls under the obligation for ongoing post-market surveillance, which includes the regular collection of safety, efficacy, and performance data.

• Manufacturers must report any adverse events, product recalls, or changes in the device’s risk profile to the NMPA.
• They must submit periodic safety update reports (PSURs), especially for high-risk devices (Class III). This is part of the continuous monitoring of the device's safety and performance in the market.
• Manufacturers should also update their technical documentation (e.g., risk management files, clinical data) based on post-market feedback, new clinical evidence, or changes in manufacturing processes.

3. Changes in the Device or Its Components

If there are any significant changes to the medical device, such as updates to the design, components, materials, intended use, or manufacturing process, the NMPA may require a review or re-registration of the product.

• Substantial Changes: Significant modifications, like changes in the device’s intended use or significant technological improvements, may trigger the need for a new registration application or re-evaluation by the NMPA.
• Minor Changes: For minor changes, manufacturers may not need to resubmit a complete registration dossier but may need to file an amendment or update.

Manufacturers should maintain close documentation on any changes made to the device and be ready to notify the NMPA accordingly.

4. Regulatory and Standards Updates

China’s regulatory environment for medical devices is constantly evolving. The NMPA periodically updates regulations, standards (e.g., GB standards), and guidelines for medical devices, which may require manufacturers to review and revise their product’s compliance.

• If there is a change in national standards (e.g., GB 9706 for medical devices or YY standards for specific medical device types), manufacturers may need to update their product documentation, perform additional testing, or make modifications to ensure continued compliance.
• ISO certification or Good Manufacturing Practice (GMP) requirements may also change, necessitating a review of the manufacturing processes or quality systems.

5. Market Access Maintenance

For foreign manufacturers, maintaining market access in China also involves ensuring that the device remains in compliance with both local regulations and market expectations.

• Chinese Distribution Network: Manufacturers need to work closely with their local authorized representatives and distributors to ensure the device remains available and properly registered in the market.
• Changes in the Distribution Channels: If the distributor or local representative changes, the NMPA needs to be notified, and new documentation may need to be submitted.

6. Foreign Device Manufacturer Inspections

The NMPA periodically conducts inspections of foreign manufacturing sites to ensure compliance with GMP and other regulatory requirements. These inspections are typically part of the registration process but may occur during the lifecycle of the device, especially for Class III devices.

• If a foreign manufacturer’s site undergoes a major inspection or audit, they may need to provide updated inspection reports to NMPA to confirm continued compliance with Chinese regulatory standards.

7. Clinical Data and Trials Updates

For certain types of medical devices, especially Class III devices, manufacturers may need to update their clinical data periodically as new research emerges or as the product is used in the market.

• If there are any new clinical trials or research findings that impact the safety or effectiveness of the device, the manufacturer may be required to submit updated data or even conduct new trials.
• The NMPA may request additional clinical evidence if the risk profile of the device changes or if new risks are identified.

8. Expiry of Registration Certificates

NMPA issues registration certificates with an expiry date for most medical devices. Class II and III devices typically have a 5-year registration period, after which they must be renewed.

• Manufacturers must submit a renewal application before the certificate expires. The renewal process may involve providing updated documentation and undergoing a review of the device’s performance and post-market data.
• If a renewal application is not submitted on time, the device may be delisted, and the manufacturer will no longer have the right to market the device in China until the renewal is completed.

9. Re-Evaluation and Re-Registration

After the initial registration, if significant changes occur to the medical device or if new risks are identified, NMPA may require a full re-evaluation or re-registration.

• Re-evaluation can be triggered by various factors such as emerging safety concerns, updates in relevant standards, or post-market surveillance findings.
• If a re-evaluation is needed, manufacturers must submit updated clinical data, safety reports, or undergo additional testing as required by the NMPA.

10. Compliance with Local Regulations and Practices

Manufacturers should maintain a relationship with a local regulatory consultant or authorized representative in China, as these professionals are essential for staying updated on changing regulations and helping with the regular review and maintenance of product registrations.

Conclusion

In summary, regular review of medical device registrations is an essential requirement to ensure that devices continue to meet NMPA’s regulatory standards in China. Manufacturers must stay proactive with annual renewals, post-market surveillance, changes to the device or its components, and updates in regulatory requirements to ensure their devices remain compliant and available for sale. The re-registration process, typically every 5 years for Class II and III devices, requires careful planning and the submission of updated documents, clinical data, and testing reports to avoid lapses in certification.