In accordance with the State Food and Drug Administration's deployment of medical device supervision and supervision, combined with the current regulatory practices, the Fujian Provincial Food and Drug Administration issued a notification in the past to require the province’s system to fully understand the daily supervision of aseptic and implantable medical devices. It is important to strengthen the supervision and inspection of such products and further regulate the order of circulation of such products.

The first is to fully understand the importance of strengthening day-to-day supervision of sterile and implantable medical devices. At present, the implementation of the "Quality Management Practice for Medical Devices (Trial)" is still in its infancy. The province's system should attach great importance to the supervision of aseptic and implantable medical devices. It must strictly follow the standards, and must not go through the motions, pay attention to actual results, and strictly implement supervision and inspection. The various provisions and requirements.

The second is to strengthen the supervision and inspection of aseptic and implantable medical device manufacturers, and regulate the production behavior of enterprises. In accordance with the "Measures for the Supervision and Management of Medical Device Production", "Regulations for the daily supervision and administration of medical device production" and the "Regulations for the Quality Management of Medical Device Production (Trial)", the organization of the development of aseptic and implantable medical device manufacturers Forms of supervision and inspection. Focus on checking whether the procurement link meets the requirements, whether the control of the clean room (area) meets the requirements, whether the sterilization process control meets the requirements, and whether the product traceability meets the requirements.

The third is to strengthen supervision and inspection of aseptic and implantable medical device operators and regulate the order of product circulation. In accordance with the relevant provisions of the “Measures for the Administration of Medical Device Operation Enterprise Licenses”, in conjunction with the inspection and acceptance standards of the operating companies and the specific requirements for supervision and inspection, the organization shall conduct supervision and inspection of the sterile and implantable medical device operating enterprises in their respective jurisdictions. Enterprises that have found problems in the supervision and inspection shall be subject to follow-up inspections and supervised reforms. The number of follow-up entrepreneurs must not be less than 20% of the number of supervisory inspections. The key inspection links include whether the business premises and storage facilities and conditions meet the requirements; whether the product quality management system is sound, and in particular whether the purchase and sales records are complete and standardized. Key examinations include pacemakers, stents, catheters, prosthetic valves, cochlear implants, artificial blood vessels, artificial crystals, artificial hip joints, artificial knee joints, bone plates, and bone nails.