(I) key points of production link inspection. Whether the regulations, specifications and standards such as the regulations on the supervision and management of medical devices, the measures for the supervision and management of medical device production, the specification for the quality management of medical device production and its relevant appendices, the regulations on the management of medical device instructions and labels, the measures for the management of adverse event monitoring and re evaluation of medical devices are fully implemented. Key inspection: (1) whether the self inspection report of the quality management system of the enterprise in the previous year, the spot check of the supervision and management department and the problems found in the inspection have been rectified; (2) whether the legal representative (person in charge of the enterprise), the management representative and relevant quality personnel have received the training and assessment of laws and regulations; (3) whether the control of the clean room (area) meets the requirements; (4) production equipment and inspection Check whether the equipment matches the product and scale; (5) whether the product change complies with the change procedure, especially after the implementation of the mandatory standard; (6) whether the procurement process meets the requirements, whether the supplier is audited and evaluated, especially whether the primary infusion device manufacturer complies with the fluorescent substance identification in the PVC infusion and transfusion device and Whether the requirements of quantitative supplementary inspection method and raw materials are controlled; (7) whether the special process and key process are identified and effectively controlled in the production process; (8) whether the sterilization process control meets the requirements, especially whether the sterility performance and ethylene oxide residue of the product meet the standard requirements, with corresponding inspection or verification records; (9) quality control and production Whether the product release conforms to the mandatory standards and registered product technical requirements; (10) whether the collection method of adverse events of medical devices suitable for the products produced is established, whether the adverse event information of medical devices is collected in time, whether the recall and other measures are taken for the medical devices with potential safety hazards, and report to the relevant departments according to the regulations. (2) key points of circulation link inspection. Whether the requirements of regulations, specifications and standards such as regulations on the supervision and administration of medical devices, measures for the supervision and administration of medical device operation, specifications for the management of medical device operation quality and guidelines for the management of cold chain (Transportation) of medical devices are fully implemented. Key inspection: (1) whether to operate (online sales) medical devices without permission (filing); (2) whether to operate (online sales) medical devices without registration certificate or filing certificate; (3) whether the purchase and sales channels are legal; (4) whether the purchase inspection records and sales records are true and complete, and whether relevant information can be traced; (5) whether to operate without certificate of conformity Specify the documents and expired, invalid and obsolete medical devices; (6) whether the transportation and storage conditions meet the labeling requirements of labels and instructions; whether the medical devices that need cold chain management are equipped with appropriate facilities and equipment; (7) whether the relevant obligations of adverse event monitoring of medical devices are fulfilled. (3) key points of inspection in use. Whether the regulations, specifications and standards such as regulations on the supervision and management of medical devices, measures for the supervision and management of the use quality of medical devices, measures for the management of adverse events monitoring and reevaluation of medical devices, and guidelines for the management of cold chain (Transportation) of medical devices are fully implemented. Key inspection: (1) whether to purchase and use medical devices that are not registered or filed according to law, without qualification certificates and expired, invalid or eliminated; (2) whether to establish a quality management system covering the whole process of quality management; (3) whether to strictly check the supplier's quality and product certificates; (4) whether to establish and implement the use of sterile and implanted medical devices Pre quality inspection system; (5) whether the use records of implanted and interventional medical devices are established, whether the use records of implanted medical devices are permanently kept, and relevant information