[Brief Discussion on the General Requirements of Quality Management System of Diagnostic Reagents Developed by Medical Institutions].

On March 19, 2021, the National Medical Products Administration(NMPA) issued the (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 diagnostic reagents developed by medical institutions. It also pointed out that the relevant administrative measures shall be formulated by the Drug Regulatory Department of the State Council in conjunction with the Health Department of the State Council. This initiative marks the re-incorporation of diagnostic reagents developed by medical institutions into China's regulatory system. This study reviewed the development of regulatory policies for self-developed diagnostic reagents at home and abroad, combined with the issued by the Shanghai Municipal Drug Administration, in conjunction with the Shanghai Municipal Health Commission, and the specific verification work of pre-record evaluation, and sorted out the general requirements for the quality management system of self-developed diagnostic reagents. The purpose is to provide some references for the further development of this pilot work and its nationwide promotion.