Yes, China’s NMPA registration of medical devices does require an updated approval process under certain circumstances. Here’s a brief overview:

1. When Updates Are Required

Changes that may necessitate a new approval process include:

• Major Changes: Significant alterations to the device's design, intended use, materials, or manufacturing processes.
• New Indications: If the device is intended for new medical conditions or patient populations.
• Change in Manufacturer: If there’s a change in the manufacturing site or manufacturer itself.

2. Types of Approval Processes

• Full Re-registration: Required for major changes that impact safety or efficacy, which involves a new application submission and potentially new clinical data.
• Notification Process: For minor changes that do not significantly affect the device's safety or efficacy, a simple notification may suffice.

3. Documentation and Review

The NMPA requires updated technical documentation, risk assessments, and, in some cases, additional clinical evaluation data for the approval process.

Conclusion

Manufacturers must carefully evaluate any changes and determine whether they require a full approval process or just a notification to ensure compliance with NMPA regulations. If you need more specifics on this process, let me know!