A Brief Discussion on the General Requirements of Quality Management System of In Vitro Diagnostic Reagents Developed by Medical Institutions

On March 19, 2021, the State Drug Administration issued the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of The State Council of the People's Republic of China), which clearly stipulated in Article 53 the basic definition and scope of use of in vitro diagnostic reagents developed by medical institutions. It also pointed out that the relevant administrative measures shall be formulated by the drug regulatory department under The State Council in conjunction with the health department under The State Council. The move marks the re-incorporation of in vitro diagnostic reagents developed by medical institutions into China's regulatory system. This study reviewed the development of regulatory policies for self-developed in vitro diagnostic reagents at home and abroad, and combined with the "Key Points of on-site Verification of self-developed in vitro diagnostic reagents in Shanghai Medical Institutions" issued by Shanghai and the specific verification work of pre-record evaluation, sorted out the general requirements for the quality management system of self-developed in vitro diagnostic reagents. The purpose is to provide some reference for the further development of the pilot work and the nationwide promotion.