The National Medical Products Administration (NMPA) has approved the “Measures for Supervision and Inspection of Clinical Trial Institutions for Medical Devices (Trial),” with the regulation set to take effect from October 1, 2024. These measures are designed to reinforce the critical role of clinical trials in confirming the safety and efficacy of medical devices prior to their market launch. According to the NMPA, clinical trial institutions are pivotal in safeguarding the quality of clinical trials and protecting the rights and interests of trial participants.
The regulatory document delineates the duties of supervisory departments at various levels, formalizes inspection requirements, outlines supervision and inspection procedures, and details the handling of inspection outcomes. It also establishes collaborative processing requirements to ensure the authenticity, precision, integrity, and traceability of clinical trial outcomes.- Flcube.com
