• Categories:Industry News
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• Time of issue:2017-10-30 13:37
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(Summary description)1、 We will deepen the reform of the examination and approval system for medical devices. 1. Encourage R & D innovation. Encourage clinical institutions and doctors to participate in the research and development of innovative medical devices. Priority shall be given to the examination and approval of innovative medical devices with product core technology invention patents and significant clinical value, as well as medical devices that are urgently needed in clinical practice and listed in the national key R & D plan and major scientific and technological projects. 2. The review and approval mechanism was improved. Improve the quality control system of evaluation. Establish a drug and medical device evaluation mechanism with clinical as the core, improve the system of indication team review, project manager, technical dispute resolution, communication and exchange, priority review, review information disclosure, etc., and gradually form a drug and medical device efficacy and safety guarantee system with technical review as the core, on-site inspection and product inspection as the support. 3. We will accelerate the reform of classified management of medical devices. Set up 16 professional groups of medical device classification technology, optimize and adjust the framework and structure of classification catalog, and issue the new version of medical device classification catalogue; research and develop 22 medical device nomenclature guidelines according to professional field setting, and gradually implement naming according to the common name of medical device; formulate coding rules of medical device and construct coding system of medical device. The database of medical device classification, naming and coding was established. 2、 We will improve the system of regulations and standards. We have basically completed the formulation and revision of supporting regulations for medical devices, accelerated the research and transformation of international standards for medical devices, given priority to improving the basic general standards and high-risk product standards for medical devices, revised the guiding principles for technical review of medical device registration, and formulated technical guidelines for the production, operation, use and adverse event monitoring of medical devices. "Medical device standard improvement action plan" includes: 1. 500 medical device standards were formulated and revised, including 80 diagnostic reagent standards, 200 active medical device standards, 220 passive medical device standards and other standards; 2. 200 guiding principles for technical review and clinical trials of medical devices were formulated and revised. 150 kinds of reference materials for in vitro diagnostic reagents were developed; 3. To establish and improve the standardized management system of medical devices, relying on the existing resources, strengthen the construction of the national medical device standard management center, and provide standard management personnel to meet the needs. 3、 Strengthen the whole process supervision. 1. We should fully implement the quality management standards for clinical trials of medical devices, strengthen the supervision and inspection of clinical trials, and crack down on the falsification of clinical data; 2. We should fully implement the quality management standard of medical device production, and strengthen the production supervision of sterile and implantable medical devices; 3. We should fully implement the quality management standards for medical devices, strengthen the quality supervision of cold chain transportation and storage, and implement the online filing and verification system for purchasing and selling business 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 purchase, acceptance, storage, maintenance, deployment and use, and timely report the adverse events of medical devices. Strengthen the use management of implantable and other high-risk medical devices. 4、 Comprehensively strengthen on-site inspection and supervision sampling inspection. Focusing on the aspects of code of conduct, process compliance, data reliability, etc., we will carry out the whole project inspection of quality management for enterprises, severely crack down on various illegal behaviors such as fraud, and urge enterprises to strictly implement relevant quality management standards. Increase the frequency of registration inspection, flight inspection and overseas inspection, and improve the inspection ability. Strengthen the inspection of sterile and implantable medical devices and in vitro diagnostic reagents. The "enhanced medical device inspection" program includes: 1. The national level carries out a full project inspection for all the third class medical device manufacturers and the second class sterile medical device manufactu