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The newly revised “Regulations on the Supervision and Administration of Medical Devices” (hereinafter referred to as the new “Regulations”) was issued, marking a new stage in my country’s medical device review and approval reform. The “Regulations on the Supervision and Administration of Medical Devices” were formulated in 2000, were comprehensively revised in 2014, and partially revised in 2017. This revision is in the face of the rapid development of the industry in recent years and the new situation of deepening reforms. In particular, the Party Central Committee and the State Council have made a series of major decisions and deployments on the reform of the drug and medical device review and approval system, and consolidate the results of the reform through laws and regulations. From the institutional level, we will further promote the innovation of medical devices, promote the high-quality development of the industry, stimulate market vitality, and meet the people’s demand for high-quality medical devices.
The highlights of the new “Regulations” are mainly manifested in the following aspects:
1. Continue to encourage innovation and promote the high-quality development of the medical device industry
Innovation is the first driving force leading the development. Since the 18th National Congress of the Communist Party of China, the Party Central Committee and the State Council have attached great importance to technological innovation, implemented an innovation-driven development strategy, and accelerated the promotion of comprehensive innovation with technological innovation as the core. Since 2014, the National Food and Drug Administration has helped more than 100 innovative medical devices and clinically urgently needed medical devices to be quickly approved for listing through measures such as building a green channel for priority review and approval of innovative medical devices. The enthusiasm for innovation of enterprises is high, and the industry is developing rapidly. In order to further implement the requirements of the Party Central Committee and the State Council to promote the adjustment and technological innovation of the medical device industry and enhance the competitiveness of the industry, this revision reflects the spirit of continuing to encourage innovation and promote industrial development on the basis of ensuring the safety and effectiveness of the public’s use of equipment. The new “Regulations” stipulate that the state formulates medical device industry plans and policies, incorporates medical device innovation into development priorities, supports the clinical promotion and use of innovative medical devices, improves independent innovation capabilities, promotes the high-quality development of the medical device industry, and will formulate and improve specific Implement the industrial planning and guiding policies of the company; improve the medical device innovation system, support basic research and applied research, and provide support in scientific and technological projects, financing, credit, bidding and procurement, medical insurance, etc.; support the establishment of enterprises or joint establishment of research institutions, and encourage The enterprise cooperates with universities and medical institutions to carry out innovation; commends and rewards units and individuals that have made outstanding contributions to the research and innovation of medical devices. The purpose of the above regulations is to further stimulate the vitality of social innovation in an all-round way, and to promote my country’s leap from a major medical device manufacturing country to a manufacturing power.
2. Consolidate the results of reform and improve the level of medical device supervision
In 2015, the State Council issued the “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices”, which sounded the clarion call for reform. In 2017, the Central Office and the State Council issued the “Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices”. The State Food and Drug Administration introduced a series of reform measures. This revision will part of the relatively mature and effective regulatory measures system. It is an important measure to consolidate existing achievements, perform regulatory responsibilities, improve regulatory standards, and serve public health. Such as implementing the medical device marketing license holder system, optimizing and integrating the allocation of industrial resources; implementing the unique identification system for medical devices step by step to further improve product traceability; adding regulations to allow extended clinical use to demonstrate regulatory wisdom.
3. Optimize the approval procedures and improve the review and approval system
A good system is the guarantee of high-quality development. In the process of revising the new “Regulations”, we carefully analyzed the deep-level system problems exposed in daily supervision work that were difficult to adapt to the needs of the new situation, fully learned from advanced international supervision experience, promoted smart supervision, and optimized the examination and approval procedures and improved the review and approval system. Improve the level of my country’s medical device review and approval system, and improve the quality and efficiency of review, review and approval. For example, to clarify the relationship between clinical evaluation and clinical trials, and to prove the safety and effectiveness of the product through different evaluation paths according to the maturity, risk and non-clinical research results of the product, reducing unnecessary clinical trial burden; changing the clinical trial approval to implied permission, shortening Approval time; registration applicants are allowed to submit product self-inspection reports to further reduce R&D costs; conditional approval is allowed for urgently needed medical devices such as the treatment of rare diseases, severely life-threatening and response to public health incidents. Meet the needs of patients under prescribed conditions; combine the experience of prevention and control of the new crown pneumonia epidemic to increase the emergency use of medical devices and improve the ability to respond to major public health emergencies.
Fourth, speed up the construction of informatization, and increase the intensity of “delegation, management, and service”
Compared with traditional supervision, informatization supervision has the advantages of speed, convenience and wide coverage. Informatization construction is one of the important tasks to improve supervision capabilities and service levels. The new “Regulations” pointed out that the state will strengthen the construction of medical device supervision and informationization, improve the level of online government services, and provide convenience for the administrative licensing and filing of medical devices. Information on medical devices filed or registered will be passed through the online government affairs of the drug regulatory department of the State Council. The platform is announced to the public. The implementation of the above measures will further improve the efficiency of supervision and reduce the cost of review and approval of registered applicants. At the same time, the public will be informed of the information of listed products in a comprehensive, accurate and timely manner, guide the public to use weapons, accept social supervision, and improve the transparency of government supervision.
5. Adhere to scientific supervision and promote the modernization of the supervision system and supervision capabilities
The new “Regulations” clearly stated that the supervision and management of medical devices should follow the principles of scientific supervision. The State Food and Drug Administration has launched a drug regulatory scientific action plan in 2019, relying on well-known domestic universities and scientific research institutions to establish multiple regulatory scientific research bases, making full use of social forces to address issues and issues in regulatory work under the new era and new situation. Challenges, research innovative tools, standards, and methods to enhance the scientific, forward-looking and adaptable supervision work. The first batch of key medical device research projects that have been carried out have achieved fruitful results, and the second batch of key research projects will soon be launched. By strengthening the scientific research of supervision and management, we will continuously implement the scientific supervision concept into the system and mechanism, and further improve the scientific, legal, international and modern level of medical device supervision.

Article source: Ministry of Justice