NMPA Issues New Guidelines on Medical Device Clinical Trial Inspection
China's National Medical Products Administration (NMPA) has released new guidelines detailing inspection criteria and evaluation principles for medical device clinical trials, effective May 1, 2025.
The guidelines aim to standardize clinical trial inspections, unify inspection scope and assessment criteria, and enhance the quality of medical device clinical trial supervision. The announcement is built upon several foundational regulations, including the Medical Device Supervision and Administration Regulations (State Council Order No. 739), Medical Device Registration and Filing Administrative Measures (SAMR Order No. 47), IVD Registration and Filing Administrative Measures (SAMR Order No. 48), and Quality Management Specifications for Medical Device Clinical Trials (2022 No. 28).
For registration applications currently under review, the NMPA has established clear handling procedures. Applications found to have authenticity issues will be rejected outright, while those with serious non-compliance will not be approved. Applications with regulatory compliance issues may continue through the review process with additional scrutiny.
Regarding already approved medical devices, the NMPA will take strict measures against cases involving authenticity issues, handling them according to Article 83 of the Medical Device Regulations. For cases of serious non-compliance, authorities will conduct comprehensive safety and effectiveness reassessments, implementing risk control measures when necessary.
The new guidelines will come into effect on May 1, 2025, replacing previous regulations from 2016 and 2018. This update reflects NMPA's ongoing commitment to strengthening oversight of medical device clinical trials and ensuring product safety and effectiveness in the Chinese market.
Detailed inspection points and evaluation principles are available in the accompanying document attached to the announcement.