Yes, medical devices typically undergo multiple reviews during the NMPA registration process in China. Here's an overview of the review stages:

1. Pre-Submission Review: Before submitting the formal application, you may seek a pre-submission consultation with the NMPA. This helps clarify regulatory requirements and ensures your submission aligns with expectations.

2. Application Review: Once your application is submitted, the NMPA conducts a preliminary review to ensure all required documentation is complete and meets submission standards. This includes a check for compliance with the applicable regulatory framework.

3. Technical Review: The NMPA carries out a detailed technical review of the medical device. This involves evaluating the safety, efficacy, and performance of the device based on the data provided, including clinical trial results, risk assessments, and technical specifications.

4. On-site Inspection: Depending on the device classification and the results of the document review, the NMPA may conduct an on-site inspection of the manufacturing facility. This inspection assesses compliance with Good Manufacturing Practices (GMP) and quality control systems.

5. Expert Evaluation: In some cases, the NMPA may seek input from external experts or review panels, especially for complex devices. This step provides additional insights into the technical aspects and safety concerns.

6. Approval or Request for Additional Information: After completing the reviews, the NMPA will either approve the registration or request additional information or clarifications. If additional data is required, the applicant must respond promptly to avoid delays.

7. Post-Market Surveillance Review: After obtaining registration, the device will be subject to ongoing monitoring and post-market surveillance to ensure continued compliance with safety and efficacy standards.

8. Renewal and Reassessment: Depending on the device and regulatory changes, periodic renewals or reassessments may be required, which can also involve reviews.

Overall, the NMPA registration process is comprehensive, involving multiple reviews to ensure that medical devices meet all necessary safety and effectiveness standards before they can be marketed in China.

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