The establishment of a long-term mechanism is a fundamental guarantee of the effectiveness of the five measures. Administration in accordance with the "whole while building, regulation and standard" requirement, combined with the newly issued "regulations on the supervision and administration of medical devices, and organization and form a complete set of medical device registration and revising, production, management, use of quality supervision, management methods and relevant specification, and adverse event monitoring and evaluation measures for the management, has introduced five department regulations and nearly 20 normative documents.
In the practice of practice, we also summarize experience, refine methods and solidify measures, and make 66 rules that conform to the actual regulations of local regulations. In the case of registration, the municipal bureau of chongqing has set up a standard for clinical examination of medical devices. The bureau of liaoning province has formulated the rules for the registration of medical devices; The municipal bureau of Beijing tried to carry out pilot projects for third party logistics in high-risk products, and developed special approval procedures for innovative medical devices, and encouraged product research and innovation. In response to the production links, the shanxi bureau has introduced the basic standards for the management of medical device production enterprises. The bureau of heilongjiang province has formulated the detailed rules for the implementation of the daily supervision and management of medical device manufacturers. In view of the operational use, the ningxia district bureau has formulated the measures for the circulation of medical devices; The jiangxi provincial administration drafted the regulations on the use of medical devices; Changsha municipal bureau of hunan province issued a notice to overhaul the medical device experience store. In response to the key regulatory variety, zhuzhou municipal bureau of hunan province formulated the method for the management of implantable high-risk medical devices; The bureau of hubei province has set up a guideline for monitoring and inspecting the production enterprise of the fixed tooth. For everyday supervision, each district has also laid down some rules and regulations, bureau of jilin province reference ISO9000 quality management system, made the management of medical device regulatory process documents; The fujian provincial bureau of fujian has developed a method for the investigation of medical devices. The xinjiang district bureau has set up the monitoring and re-evaluation expert library management methods for medical devices.
In carrying out the "five regulation" in the process of the special operation, the food and drug supervision departments at all levels constantly sum up experience, innovative regulatory means, rich regulatory model, gradually explore some practical and effective means and method. The collaboration mechanism, shandong, hunan, tianjin, jiangsu and other provinces (municipalities) and minor, industry and commerce, health and other multi-sectoral cooperation joint conference system, set up department regulation force; Guangxi district bureau organization system food and drug inspection personnel and public security law enforcement personnel participate in the "five management" training. In the case of regulatory informationization, the sichuan bureau has set up an electronic monitoring platform to conduct product inquiry, remote monitoring and sampling management, which greatly improves the efficiency of supervision. In the construction of the supervision team, the chongqing municipal bureau has set up an instrument appraisal and accreditation center to improve the performance of the examination and verification of the registration and the inspection of production and operation; The anhui provincial bureau of food and drug administration has conducted training on the supervision of the supervision of medical instruments in the county level. The guangdong bureau of guangdong province has shifted the focus of the regulatory focus and transformed the post-mortem treatment into proactive prevention, establishing and implementing a separate system. In the case of social governance, the ministry of gansu has set up a "red blacklist" system to expose illegal enterprises and strengthen social supervision. The municipal bureau of tianjin plays the role of industry association, conducts investigation and research, and promotes the development of the standard of concentrated industry in hemodialysis. The bureau of jiangsu province actively mobilises the awareness of well-known enterprises and builds up the "united front" of political and business cooperation.