NMPA to Strengthen Supervision of Medical Device Clinical Trial Institutions
On June 7, Li Li, the Secretary of the Party Leadership Group and Commissioner of the National Medical Products Administration (NMPA), presided over a meeting to discuss and plan the enhancement of medical device clinical trial supervision. The meeting resulted in the approval of the "Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)."
The meeting emphasized the critical role of clinical trials in ensuring the safety and efficacy of medical device products prior to their market release. Clinical trial institutions are vital in maintaining trial quality and protecting the rights and well-being of trial subjects. The new "Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)" clarify the responsibilities of different regulatory levels, institutionalize inspection procedures, outline the protocols for conducting inspections, describe the appropriate handling of various inspection outcomes, and emphasize the need for coordinated regulatory actions.
These measures aim to guide regulatory agencies at all levels in strengthening the management of medical device clinical trial institutions, standardizing supervision and inspection activities, and effectively managing risks. Furthermore, they ensure that clinical trial institutions uphold the rights and safety of participants, conduct trials according to established norms, and guarantee that trial results are authentic, accurate, complete, and traceable.
The "Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)" will be officially implemented on October 1, 2024. Following this, the NMPA will release detailed "Key Points and Judgment Principles for the Supervision and Inspection of Medical Device Clinical Trial Institutions" and will organize training sessions to promote understanding and compliance. These initiatives aim to enhance the inspection capabilities and standards of drug regulatory departments.