Recently, the Guangdong Provincial Food and Drug Administration organized the first batch of unannounced inspection work deployment meetings for medical device manufacturers in 2020, and carried out unannounced inspections on the province’s major production enterprises of epidemic prevention and control medical devices, sterile and implantable medical devices, etc. . The inspection will adhere to problem-oriented, strengthen risk management, find and eliminate hidden risks. Manufacturers of medical devices for epidemic prevention and control, 5 major categories (new coronavirus detection reagents, medical masks, medical protective clothing, ventilators, infrared thermometers) export medical device manufacturers, sterile and implantable medical device manufacturers, etc. High-risk areas, high-risk enterprises, and high-risk varieties are inspected, focusing on the compliance of production enterprises’ laws and regulations, the operation of the production quality management system, raw material procurement control, production control, quality control, and adverse event monitoring. The inspection adopts the team leader responsibility system, without prior notice before the inspection, administrative penalties are imposed on violations of laws and regulations found during the inspection, and the inspection results will be notified to the whole province after the inspection