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. Priority review and approval shall be implemented for innovative medical devices with invention patents of product core technology and significant clinical value, as well as drugs and medical devices in urgent clinical need listed in the national key R&D plan and major scientific and technological projects.

2. Improve the review and approval mechanism.

Improve the review quality control system. Establish a clinical-centered drug and medical device review mechanism, improve the system of indication team review, project manager, 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 for the efficacy and safety guarantee system of drugs and medical devices.

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

Set up 16 professional groups of medical device classification technology, optimize and adjust the framework and structure of the classification catalog, and release a new version of the "Medical Device Classification Catalog"; research and formulate 22 medical device nomenclature guidelines according to professional fields, and gradually implement naming by the general name of medical devices; Formulate coding rules for medical devices and build a coding system for medical devices. Establish a database of medical device classification, nomenclature and coding.

2. Improve the system of regulations and standards.

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

The "Medical Device Standard 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 device and other standards;

2. Formulate and revise 200 guiding principles for medical device technical review and clinical trials. Developed 150 standard substances for in vitro diagnostic reagents;

3. Establish and improve the medical device standardization management system, relying on existing resources, strengthen the construction of the national medical device standard management center, and allocate standard management personnel to meet the needs.

Third, strengthen the supervision of the whole process.

1. Fully implement the quality management standard for clinical trials of medical devices, strengthen the supervision and inspection of clinical trials, and severely crack down on the fraud of clinical data;

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

3. Fully implement the quality management standards for medical device operation, strengthen the quality supervision of cold chain transportation and storage, and implement the online filing and verification system for the purchase and sales personnel of 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 medical device adverse events in a timely manner. Strengthen the management of the use of implantable and other high-risk medical devices.

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

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

The “Enhanced Medical Device Inspection” plan includes:

1. The national level conducts a full-item inspection of all third-class medical device manufacturers and second-class sterile medical device manufacturers every year. Beginning in 2018, a full-item inspection will be conducted every two years for the remaining Class II medical device manufacturers and all Class I medical device manufacturers.

2. Carry out inspections on the quality management systems of 30-40 overseas medical device manufacturers every year, and realize full coverage of imported high-risk medical device products during the "Thirteenth Five-Year Plan" period.

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

4. Full coverage inspection of the use of medical devices in tertiary A-level medical institutions every year, and full coverage inspection of other users during the "Thirteenth Five-Year Plan" period.

Fifth, strengthen supervision and sampling.

Reasonable division of national and local varieties and projects for random inspection, increase the intensity of random inspection of high-risk varieties, and expand the coverage of random inspection.

At the national level, 40-60 kinds of medical device products are supervised and tested every year.

6. 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 reviewers with scientific research institutes and hospitals. Improve and perfect the drug and medical device review and approval database.

7. Inspection and testing capacity building.

Compile standards for medical device inspection and testing capacity building, rely on China National Institute for Food and Drug Control to build national-level medical device inspection and testing institutions, and transform 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 for commonly used medical devices and the inspection and testing platform for high-risk medical devices. Carry out research on on-site inspection methods, testing platforms and equipment of in-use medical devices.

8. Capacity building for adverse reactions and adverse events monitoring.

The ability to monitor and evaluate medical device adverse events has reached the international advanced level.

Use the electronic data of medical institutions to establish an active monitoring and evaluation system for the safety of drugs and medical devices. Set up 300 sentinel monitoring sites 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 adverse events of medical devices reaches more than 80%.

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

Strengthen the research on the safety evaluation technology and standard system of medical devices, 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.