The clean room (area) is an indispensable production environment for the production of sterile medical devices and in vitro diagnostic reagents. The level of environmental control directly or indirectly affects the quality of medical device products. This checkpoint guide is intended to help Beijing medical device supervisors to enhance their knowledge and understanding of the relevant processes of medical device clean rooms (areas), and to guide the supervision of medical device supervisors in the city on the control level of clean room (district) of medical device manufacturers. checking work. At the same time, it provides reference for the management requirements of medical device manufacturers in the clean room (area).