Yes, the NMPA registration process for medical devices in China can involve multiple rounds of review. The specific details can vary based on the type and classification of the medical device, as well as the documentation and responses provided by the manufacturer. Here are some key points regarding the review process:

### 1. **Initial Submission Review**

- **Comprehensive Review**: Upon the initial submission of the registration application, the NMPA conducts a comprehensive review of all provided documents, including technical files, clinical data, risk assessments, and quality management system details.

- **Provisional Feedback**: The NMPA may provide provisional feedback on deficiencies or additional information needed during this stage.

### 2. **Clarification and Additional Information Requests**

- **Requests for Clarifications**: If the reviewers find incomplete information or require further clarification on specific points, they will issue a request to the manufacturer.

- **Response and Resubmission**: Manufacturers are required to respond to these requests, often resulting in additional analyses or data submissions. This is a critical stage where the quality and clarity of the provided information can significantly impact the process.

### 3. **Technical Review Process**

- **Expert Assessment**: Once the initial documentation is accepted, it goes through a technical review by experts in the relevant field. This might involve multidisciplinary teams assessing the safety and efficacy of the device.

- **Iterative Rounds**: Depending on the findings, there can be several rounds of reviews, especially for complex devices or those with unique features. Each round may lead to further inquiries or requests for additional evidence.

### 4. **On-Site Inspections**

- **Factory Inspections**: For certain higher-risk devices, the NMPA may require on-site inspections of the manufacturing facilities. This adds another layer of review to ensure compliance with GMP (Good Manufacturing Practices) standards.

- **Follow-Up Inspections**: If deficiencies are found during these inspections, manufacturers may need to address issues and submit the corrections, which can lead to another review cycle.

### 5. **Final Approval Stage**

- **Final Evaluation**: Once all reviews and corrections are satisfactorily addressed, the NMPA will conduct a final evaluation to decide whether to grant registration.

- **Registration Certificate Issuance**: If approved, the registration certificate is issued, allowing the device to enter the Chinese market.

### 6. **Post-Approval Requirements**

- **Ongoing Compliance Review**: Even after registration, ongoing compliance with post-market surveillance and reporting obligations is necessary, which can involve further reviews if issues arise.

### Conclusion

The NMPA registration process is iterative and may involve multiple rounds of review, especially if additional information is requested or if deficiencies are identified at any stage. Manufacturers should be prepared for this possibility and ensure thorough preparation of documentation to expedite the process. If you have further questions about specific stages or strategies, feel free to ask!

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