NMPA Seeks Feedback on Draft Regulations for Clinical Trial Institutions Supervision
China's National Medical Products Administration (NMPA) is soliciting feedback on the draft regulations for the supervision and inspection of clinical trial institutions for medical devices. These regulations aim to strengthen the management of these institutions and standardize the supervision and audit processes.
These audit guidelines apply to the supervision and inspection of clinical trial institutions for medical devices organized by the drug regulatory authorities. The on-site audit may focus on specific inspection points based on the type of audit and key areas.
Audit Content: There are a total of 16 audit sections and 96 audit items, divided into two parts: institution and clinical trial profession. The on-site audit content covers aspects such as conditions and filing management, operational management, and more.
Principles of Determination: Defects identified during inspections are categorized as severe, major, or general defects. Key items that do not meet requirements are classified as severe defects, major items as major defects, and general items as general defects. The severity of defects is assessed based on the importance, deviation degree, and quality and safety risks of the corresponding inspection points. Conclusions are drawn separately for institutions and professions.
TX Medical has extensive experience in clinical trials, has undergone NMPA audits, and ensures compliance with clinical trials. For any inquiries, please contact us at contact@txcro.com.