Health, population and family planning, quality and technical supervision departments shall, within the scope of their respective duties, do a good job in the supervision and management of medical devices in medical institutions. Article 5 Medical institutions shall establish medical device files and medical device ledgers, strengthen the management of medical device use, and ensure the safe and effective use of medical devices. Article 6 Medical institutions that use medical devices shall register with the food and drug supervision and administration departments at the county level. The contents of filing and registration include: name, address, legal representative, person in charge, medical device registration category, etc. If the contents of the record registration are changed, the medical institution shall inform the food and drug supervision and administration department in writing within 30 days after the change. Article 7 A medical institution shall set up a medical device management institution or be equipped with medical device management personnel to be responsible for the medical device management of its own unit. Article 8 Medical institutions shall have corresponding technical personnel and environmental conditions when using medical devices. Article 9 Medical institutions shall establish and implement management systems for the procurement, acceptance, storage, use, maintenance, disinfection, scrapping and disposal of medical devices. Article 10 Medical institutions shall verify the legal qualifications of medical device suppliers and keep relevant information. Article 11 Medical institutions shall conduct quality inspection when purchasing medical devices. The acceptance contents include: product name, specification, model, manufacturer, supplier, registration certificate, medical device registration form, certificate of conformity, production date, production batch number, sterilization batch number, expiration date, purchase date, etc. After acceptance, the quality acceptance record shall be filled in and kept for future reference after being signed by the acceptance personnel.
Medical devices that need to be subject to compulsory product certification or included in the catalogue of national industrial product production licenses shall also include compulsory product certification or industrial product production license certificates. Twelfth medical institutions should conduct testing or verification before using reusable medical devices, and those that do not meet the performance requirements of medical devices shall not be used. Thirteenth medical institutions to buy a single medical device worth more than 300 thousand yuan, it should be a copy of the legal certificate of medical device products reported to the district and county food and drug supervision and management departments. The food and drug supervision and administration department shall provide consulting services on the legality of medical device products and other related contents. Article 14 The storage of medical devices shall be partitioned and classified, and equipped with corresponding facilities such as padding, shelves, moisture-proof, insect-proof, rat-proof, fire-fighting, ventilation and light-proof. Fifteenth medical institutions to use disposable sterile medical devices shall comply with the relevant provisions of the state, and establish records of purchase, distribution, recycling, disinfection and destruction. Equipped with disinfection and destruction facilities, master the whereabouts of waste.
Disposable sterile medical devices included in the centralized disposal of medical wastes shall be directly handled by the centralized disposal unit of medical wastes. Sixteenth medical institutions should use implantable medical devices in accordance with the relevant provisions of the state, set up special counters for safekeeping, and establish records of purchase, acceptance and distribution. Copies of product certificate, registration certificate and medical device registration form shall be kept together with medical records. Article 17 Medical institutions that use large-scale medical equipment shall establish records of the use and maintenance of medical equipment, which shall be properly kept for future reference. Eighteenth medical institutions medical device quality accidents, medical device adverse events, it should be timely to the food and drug supervision and management departments and medical device adverse reaction monitoring agencies. Nineteenth city, district and county food and drug supervision and management departments can seal up and detain medical devices and related materials that cause quality accidents of medical devices or have potential safety hazards. Twentieth medical institutions in the use of medical devices found in the process of suspicious quality, should suspend the use, timely transfer to the medical device testing institutions for inspection, and report to the food and drug supervision and management department. Twenty-first medical institutions should report the name, specification, model, service life and disposal methods of medical devices to the district and county food and drug supervision and management departments when eliminating a single medical device with a value of more than 300,000 yuan. Twenty-second medical institutions that undertake clinical trials or clinical verification of medical devices shall abide by relevant state regulations and provide true and complete clinical trials or clinical verification reports. Twenty-third medical institutions should establish health records of medical device operators. Twenty-fourth food and drug supervision and management departments should strengthen the supervision and inspection of medical devices in medical institutions, and the relevant units and individuals shall not refuse or conceal them. No fees shall be charged for random inspection of medical devices.