1. Deepen the reform of the medical device review and approval system.

　　 1. Encourage R&D and innovation.

　　 Encourage clinical institutions and doctors to participate in the research and development of innovative medical devices. Prioritize review and approval of innovative medical devices with product core technology invention patents and significant clinical value, as well as clinically urgently needed drugs and medical devices listed in the national key research and development plan and major scientific and technological projects.

　　 2. Improve the review and approval mechanism.

　　 Improve the review quality control system. Establish a clinical-centric drug and medical device review mechanism, improve the indication team review, project managers, technical dispute resolution, communication, priority review, review information disclosure, etc., and gradually form a technical review as the core , On-site inspection and product inspection as the support of the efficacy and safety guarantee system of medicines and medical devices.

　　 3. Speed ​​up the reform of medical device classification management.

Established 16 medical device classification technology professional groups, optimized and adjusted the classification catalog framework and structure, released a new version of the "Medical Device Classification Catalog"; researched and formulated 22 medical device naming term guides according to professional field settings, and gradually implemented naming according to the general name of medical devices; Formulate medical device coding rules and build a medical device coding system. Establish a medical device classification, naming and coding database.

　　 Second, improve the legal and standard system.

Basically complete the revision of the supporting regulations for medical devices; accelerate the research and transformation of international medical device standards, give priority to improving the basic general standards of medical devices and high-risk product standards; revise the guiding principles of medical device registration technical review, and formulate the production, operation, use and adverse events of medical devices Monitoring technology guide.

　　"Medical Device Standards Improvement Action Plan" includes:

　　1. Formulate and revise 500 medical device standards, including 80 diagnostic reagent standards, 200 active medical device standards, and 220 passive medical devices and other standards;

　　2, formulate and revise 200 medical device technical review and clinical trial guidelines. Develop 150 kinds of in vitro diagnostic reagent standard materials;

　　3. Establish a sound medical device standardization management system, rely on existing resources, strengthen the construction of a national medical device standard management center, and provide standard management personnel that meet the needs.

　　 3. Strengthen the supervision of the whole process.

　　1. Fully implement the medical device clinical trial quality management standards, strengthen clinical trial supervision and inspection, and severely crack down on clinical data fraud;

　　2. Fully implement the medical device production quality management practices, and strengthen the supervision of sterile and implantable medical devices;

　　3. Fully implement the medical device operation quality management standard, strengthen the supervision of the quality of cold chain transportation and storage, and implement the online filing and verification system for the purchase and sale personnel of the production and operation enterprises;

　　4. Strictly implement the quality supervision and management measures for the use of medical devices, strictly control the quality of each link of purchase, acceptance, storage, maintenance, deployment and use, and report adverse events of medical devices in a timely manner. Strengthen the use and management of implantable and other high-risk medical devices.

　　 Fourth, comprehensively strengthen on-site inspection and supervision and random inspection.

　　 Focusing on standards of behavior, process compliance, data reliability, etc., the company conducts overall quality management project inspections, cracks down on fraud and other illegal activities, and urges companies to strictly implement relevant quality management standards. Increase the frequency of registration inspections, unannounced inspections and overseas inspections to improve inspection capabilities. Intensify the inspection of sterile, implantable medical devices and in vitro diagnostic reagents.

　　 "Strengthening Medical Device Inspection" plan includes:

　　 1. The national level conducts a full project inspection every year for all the third-class medical device manufacturers and the second-class sterile medical device manufacturers. Since 2018, a full project inspection will be carried out every two years for the remaining second-class medical device manufacturers and all first-class medical device manufacturers.

　　2. The quality management system of 30-40 overseas medical device manufacturers will be inspected every year. During the "13th Five-Year Plan" period, full coverage inspection of imported high-risk medical device products will be realized.

　　3. Annual full coverage inspections for operating companies that have special requirements for storage and transportation, during the "13th Five-Year Plan" period, full coverage inspections for companies operating sterile, implantable medical devices and in vitro diagnostic reagents will be realized.

　　4. The use of medical devices in tertiary and A-level medical institutions shall be fully covered every year. During the "13th Five-Year Plan" period, full coverage inspection of other users will be realized.

　　 5. Strengthen supervision and random inspection.

　　 Reasonably divide the national and local sampling inspection varieties and items, increase the sampling inspection of high-risk varieties, and expand the sampling inspection coverage.

　　The national level conducts supervision and sampling inspections on 40-60 kinds of medical device products every year.

　　 6. The construction of a national-level review center.

　　 Explore the institutional mechanism and corporate governance model of innovative drug and medical device review institutions. Reform the employment mechanism of public institutions, establish a reasonable incentive and restraint mechanism, and jointly train review personnel with scientific research institutes and hospitals. Complete and perfect the database of drug and medical device review and approval.

　　 Seven, inspection and testing capacity building.

　　 Prepare medical device inspection and testing capacity building standards, rely on China Food and Drug Control Research Institute to build a national-level medical device inspection and testing institution, and upgrade and upgrade provincial-level medical device inspection institutions. Build a batch of key laboratories for medical device supervision.

　　 Carry out research on the quality evaluation, testing technology and testing specifications of various digital diagnosis and treatment equipment, individualized diagnosis and treatment products, and biomedical materials, and strengthen the research on the rapid inspection system of commonly used medical devices and the inspection and testing platform for high-risk medical devices. Carry out on-site inspection methods, inspection platforms and equipment research for medical devices in use.

　　 8. Adverse reactions and adverse event monitoring capacity building.

　　Medical device adverse event monitoring and evaluation capabilities have reached the international advanced level.

　　 Use the electronic data of medical institutions to establish an active monitoring and evaluation system for the safety of medicines and medical devices. Set up 300 monitoring sentinels for adverse drug reactions and medical device adverse events in general hospitals. Carry out key monitoring on 100 medical device products. The proportion of counties (cities, districts) reporting medical device adverse events reached over 80%.

　　 Nine. Research on the safety evaluation system of medical devices.

　　 Strengthen the research of medical device safety evaluation technology and standard system, systematically carry out research on the safety of high-risk medical devices such as implantability, and carry out research on the standard system of innovative medical devices such as medical robots and medical additive manufacturing.