Yes, the application for extension (or renewal) of NMPA registration for medical devices in China does need to undergo a review process. Here’s a breakdown of how it works:

### Renewal Process for NMPA Registration

1. **Application Submission**: 

   - Manufacturers must submit a renewal application to the NMPA at least **90 days** before the expiration of the existing registration. This application includes updated documentation and any relevant information about the device.

2. **Review Requirements**:

   - The NMPA will review the renewal application to ensure that the medical device continues to meet the necessary safety, efficacy, and quality standards applicable to its classification (Class I, II, or III).

   - During the review, the NMPA may assess:

     - Any changes to the device or its production process since the original registration.

     - Results from post-market surveillance, including any adverse event reports or product quality issues.

     - Compliance with regulatory changes that may have occurred during the previous registration period.

3. **Possible Additional Documentation**:

   - In some cases, particularly if there have been significant changes or updates to the regulations, the NMPA might request additional documentation or data. This could include new clinical data, risk assessments, or updates to the quality management system.

4. **Response Timeframe**:

   - The review of a renewal application usually takes a similar timeframe to the initial registration process, often from **three to six months**, but this can vary based on the amount of information submitted and the complexity of the device.

5. **Approval or Rejection**:

   - If the application meets all necessary requirements, the NMPA will approve the renewal. If not, the application can be rejected, and the manufacturer may need to address any deficiencies identified during the review process.

### Conclusion

Renewing NMPA registration for medical devices in China is a formal process that requires a thorough review by the NMPA to ensure continued compliance with regulatory standards. It is crucial for manufacturers to prepare and submit their renewal applications in a timely and comprehensive manner to avoid delays in maintaining their market authorization.

If you have further questions or need more details on a specific aspect of the renewal process, feel free to ask!

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