I. Deepening the Reform of the Medical Device Review and Approval System

　　1. Encouraging Research and Development Innovation

　　Encourage clinical institutions and doctors to participate in the research and development of innovative medical devices. Priority review and approval will be implemented for innovative medical devices with core technological invention patents and significant clinical value, as well as urgently needed clinical drugs and medical devices included in the national key research and development plan and major science and technology projects.

　　2. Improving the Review and Approval Mechanism

　　Improve the quality control system for review. Establish a clinical-centric review mechanism for drugs and medical devices, improve the systems for adaptive indication team review, project managers, technical dispute resolution, communication and exchange, priority review, and public disclosure of review information, gradually forming a drug and medical device efficacy and safety assurance system with technical review as the core, and on-site inspections and product testing as support.

　　3. Accelerating the Reform of Medical Device Classification Management

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

　　II. Improving the Regulatory and Standard System

　　Basically complete the revision and amendment of supporting regulations for medical devices; accelerate the research and transformation of international medical device standards, prioritize improving basic general standards for medical devices and standards for high-risk products; revise guiding principles such as technical review of medical device registration, and formulate technical guidelines for the production, operation, use, and adverse event monitoring of medical devices.

　　"Action Plan for Improving Medical Device Standards" 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. Develop 150 types of standard substances for in-vitro diagnostic reagents; 150 types of reagent standard substances;

　　3. Establish and improve a standardized management system for medical devices, relying on existing resources, strengthen the construction of the National Medical Device Standards Management Center, and equip it with the necessary standard management personnel.

　　III. Strengthening Full-Process Supervision

　　1. Fully implement the quality management specifications for medical device clinical trials, strengthen supervision and inspection of clinical trials, and severely crack down on the falsification of clinical data;

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

　　3. Fully implement the quality management specifications for medical device operation, strengthen quality supervision of cold chain transportation and storage, and implement an online registration and verification system for production and operation enterprise purchase and sales personnel;

　　4. Strictly implement the methods for quality supervision and management of medical device use, strictly control the quality of each link of procurement, acceptance, storage, maintenance, allocation, and use, and promptly report adverse events of medical devices. Strengthen the management of the use of high-risk medical devices such as implantable devices.

　　IV. Comprehensive Strengthening of On-site Inspections and Supervision and Spot Checks

　　Focusing on behavioral norms, process compliance, and data reliability, conduct full-project inspections of enterprises' quality management, severely crack down on various illegal acts such as falsification, and urge enterprises to strictly implement relevant quality management specifications. Increase the frequency of registration inspections, flying inspections, and overseas inspections, and improve inspection capabilities. Increase the intensity of inspections of sterile, implantable medical devices and in-vitro diagnostic reagents.

　　"Strengthening Medical Device Inspections" plan includes:

　　1. At the national level, conduct a full-project inspection of all Class III medical device manufacturers and Class II sterile medical device manufacturers annually. Starting in 2018, conduct a full-project inspection of the remaining Class II medical device manufacturers and all Class I medical device manufacturers every two years.

　　2. Conduct inspections of the quality management systems of 30-40 overseas medical device manufacturers annually, and achieve full coverage inspection of imported high-risk medical device products during the 13th Five-Year Plan period.

　　3. Conduct full-coverage inspections of operating enterprises with special requirements for storage and transportation annually, and achieve full-coverage inspections of enterprises operating sterile, implantable medical devices and in-vitro diagnostic reagents during the 13th Five-Year Plan period.

　　4. Conduct full-coverage inspections of the use of medical devices in Class A tertiary hospitals annually, and achieve full-coverage inspections of other users during the 13th Five-Year Plan period.

　　V. Strengthening Supervision and Spot Checks

　　Reasonably divide the varieties and items of national and local spot checks, increase the intensity of spot checks on high-risk varieties, and expand the coverage of spot checks.

　　At the national level, conduct supervision and spot checks on 40-60 types of medical device products annually.

　　VI. Construction of the National Review Center

　　Explore innovative institutional mechanisms and corporate governance models for drug and medical device review agencies. Reform the personnel mechanism of public institutions, establish a reasonable incentive and restraint mechanism, and jointly cultivate reviewers with scientific research institutions and hospitals. Improve and perfect the drug and medical device review and approval database.

　　VII. Construction of Inspection and Testing Capabilities

　　Develop standards for the construction of medical device inspection and testing capabilities, rely on the China Food and Drug Administration to build a national-level medical device inspection and testing institution, and transform and upgrade provincial-level medical device inspection institutions. Build a number of key laboratories for medical device supervision.

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

　　VIII. Construction of Adverse Reaction and Adverse Event Monitoring Capabilities

　　The monitoring and evaluation capabilities for medical device adverse events have reached internationally advanced levels.

　　Utilize electronic data from medical institutions to establish an active monitoring and evaluation system for drug and medical device safety. Establish 300 sentinel points for monitoring adverse drug reactions and adverse events of medical devices in comprehensive hospitals. Conduct key monitoring of 100 medical device products. The reporting rate of medical device adverse events at the county (city, district) level reaches more than 80%.

　　IX. Research on Medical Device Safety Evaluation System

　　Strengthen research on medical device safety evaluation technology and standard systems, systematically conduct safety research on high-risk medical devices such as implantable devices, and conduct research on standard systems for innovative medical devices such as medical robots and medical additive manufacturing.