To regulate the inspection of medical device clinical trials, standardize the scope of inspection and criteria for determination, and improve the quality of inspections for medical device clinical trial, the National Medical Products Administration (NMPA) has organized the revision of the “Key Points and Determination Principles for the Inspection of Medical Device Clinical Trial” in accordance with the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739), the Measures for the Administration of Medical Device Registration and Filing (SAMR Order No. 47), the Measures for the Administration of In Vitro Diagnostic Reagent Registration and Filing (SAMR Order No. 48), and the Good Clinical Practice for Medical Devices (No. 28 of 2022). The relevant matters are hereby announced as follows:

 

1. Legal Basis for Inspections

The drug regulatory authorities shall conduct inspections of medical device clinical trial in accordance with the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of Medical Device Registration and Filing, the Measures for the Administration of In Vitro Diagnostic Reagent Registration and Filing, and the Good Clinical Practice for Medical Devices, among other relevant regulations.

 

2. Handling of Authenticity Issues during Registration Review

For registration applications under review where the inspection results indicate issues regarding authenticity, the application product shall not be registered pursuant to Article 59, Item 3 of the Measures for the Administration of Medical Device Registration and Filing or Article 58, Item 3 of the Measures for the Administration of In Vitro Diagnostic Reagent Registration and Filing, and shall be handled in accordance with Article 78 of the Administrative License Law of the People’s Republic of China.

 

3. Handling of Serious Non-Compliance during Registration Review

For registration applications under review where the inspection results determine that there are serious non-compliance issues, the application product shall not be registered in accordance with Article 59, Item 5 of the Measures for the Administration of Medical Device Registration and Filing or Article 58, Item 5 of the Measures for the Administration of In Vitro Diagnostic Reagent Registration and Filing.

 

4. Handling of Regulatory Compliance Issues during Registration Review

For registration applications under review where the inspection results are determined to involve regulatory compliance issues (i.e., procedural or documentation irregularities), the drug regulatory authorities shall continue with the review and approval procedures.

 

5. Post-Approval Handling of Authenticity Issues

For products that have already obtained administrative approval, if the inspection results indicate issues of authenticity, they shall be handled in accordance with Article 83, Paragraph 1 of the Regulations on the Supervision and Administration of Medical Devices.

 

6. Post-Approval Handling of Serious Non-Compliance

For products that have already obtained administrative approval, if the inspection results indicate serious non-compliance, the drug regulatory authorities shall organize an assessment of the safety and effectiveness of the registered medical device; when necessary, appropriate risk control measures shall be taken.

 

7. Effective Date and Repeal of Previous Notices

For other violations of laws and regulations discovered during the inspection, such cases shall be handled in accordance with the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of Medical Device Registration and Filing, the Measures for the Administration of In Vitro Diagnostic Reagent Registration and Filing, and the Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial), among other applicable provisions.

 

8. Effective Date and Repeal of Previous Notices

This Announcement shall take effect on May 1, 2025. The "Notice of the China Food and Drug Administration on Carrying Out Supervision and Spot Checks on Medical Device Clinical Trials" (No. 98 of 2016) and the "Notice of the General Office of the National Medical Products Administration on Issuing the Key Points and Determination Principles for the Inspection of Medical Device Clinical Trials" (Yaojian Zongxiejianzhu [2018] No. 45) shall be repealed simultaneously.

 

Conclusion

The newly revised Key Points and Determination Principles by the NMPA mark a significant step toward improving regulatory transparency and ensuring the quality of medical device clinical trials in China. Compliance with these updated requirements will be essential for manufacturers seeking market entry and maintaining approvals.

 

Stay Ahead with Professional Support

Stakeholders involved in medical device clinical trials should promptly familiarize themselves with the updated regulations to ensure full compliance by May 1, 2025.

If you require guidance or support in aligning your projects with the new NMPA requirements, please feel free to contact us for professional assistance!

 

 

Reference:

Announcement of the National Medical Products Administration on Issuing the Key Points and Determination Principles for the Inspection of Medical Device Clinical Trial (No. 22 of 2025)