citation
Gao Guo-Biao, ZHANG Shi-Qing, Pan Shuo,仉琪, WANG Ying, WANG Yingjun *. Discussion on policy status and development path of innovative medical devices [J]. China Food and Drug Regulation,2024(9):6-15. (in Chinese)
Discussion on current situation and development path of innovative medical device policy
Gao Guobiao
State Drug Administration medical device technical evaluation center
GAO Guo-biao
Center for Medical Device Evaluation, NMPA
Zhang Shiqing
State Drug Administration medical device technical evaluation center
ZHANG Shi-qing
Center for Medical Device Evaluation, NMPA
Pan Shuo
State Drug Administration medical device technical evaluation center
PAN Shuo
Center for Medical Device Evaluation, NMPA
Zhang Qi
State Drug Administration medical device technical evaluation center
ZHANG Qi
Center for Medical Device Evaluation, NMPA
Wang Ying
State Drug Administration medical device technical evaluation center
WANG Ying
Center for Medical Device Evaluation, NMPA
WANG Ying-jun*
Guangdong Institute of Advanced Biomaterials and Medical Devices
NMPA Research Base of Regulatory Science for Medical Devices
NMPA Key Laboratory for Research and Evaluation of Innovative Biomaterials for Medical Devices
摘 要 / Abstract
Innovation is essential for driving the high-quality development of China's medical device industry. This paper analyses domestic policies that encourage medical device innovation, summarizes relevant international experience, and examines the challenges faced by innovative medical devices. The paper also puts forward a development path of "promoting deep integration of the innovation chain, industrial chain, capital chain, and talent chain" by focusing on policy research, implementation, and commercialization pathways.
關(guān) 鍵 詞 / Key words
new quality productivity; medical devices; innovation; high-quality development; four-chain integration
project
Research topic of innovative product transformation system of China Drug Supervision and Administration Research Society
The Third Plenary Session of the 20th Central Committee of the Party emphasized in further comprehensively deepening reform and promoting Chinese-style modernization deployment that it is necessary to build a system and mechanism to support comprehensive innovation and improve the mechanism to support the development of innovative drugs and medical devices. Supporting innovation and service innovation, as important measures to deepen reform, promote and interact with each other, and constantly stimulate the potential and vitality of high-quality development of the industry.
The remarkable feature of new quality productivity is innovation, including innovation at the level of technology and business mode, as well as innovation at the level of management and system. We must continue to do a good job of innovation, accelerate the development of new quality productive forces, and further promote and plan to comprehensively deepen reform.
New quality productivity is innovation plays a leading role. For the medical device industry, to cultivate and develop new quality productivity, it is necessary to take innovation as the core competitiveness, innovate the traditional industrial development mode and production path, develop advanced production formats with high-tech, high efficiency, high quality characteristics, in line with the new development concept, and promote the realization of technological revolutionary breakthroughs, innovative allocation of production factors and industrial transformation and upgrading. The new quality productivity represented by innovative medical devices, with subversive technological innovation and innovative production factors, is conducive to improving production efficiency, reducing production energy consumption, improving product quality, constantly breaking through the bottleneck of industrial development, solving the "jam neck" problem, and effectively providing new momentum required for the upgrading and transformation of the medical device industrial structure. Around the world, countries are actively laying out the industries of the future. Take innovative medical devices as the entry point to cultivate new quality productivity, concentrate on the key core technology battle, achieve high-level scientific and technological self-reliance in the field of medical devices, promote China's medical device industry to accelerate towards the high-end of the global value chain, and seize the commanding heights of industrial competition.
At the same time, the high-quality development of the medical device industry also provides the possibility for cultivating new quality productivity. On the one hand, the orderly development of the industry provides a rich variety of application scenarios for new quality productivity, and accelerates the transformation of innovative medical device achievements. On the other hand, the process of industrial development continues to generate new market demand, such as higher expectations for the safe and effective accessibility of medical devices, and guide the industry to develop in the direction of more in line with actual needs when cultivating new quality productivity, so as to continue to stimulate innovation vitality.
01
Current situation of innovative medical device policy in China
The innovative medical devices described in this paper are generally considered to achieve innovation in working principle or mechanism of action through new design concepts, new technologies and new materials, achieve fundamental improvements in the performance or safety of medical device products, effectively improve the effects of medical diagnosis, treatment, monitoring and rehabilitation, and improve the quality of life of patients and the efficiency of medical services. Devices with significant clinical application value.
System innovation is an important guarantee for the development of new quality productivity of medical devices. In order to meet the needs of technological progress and industrial development, national departments have issued a number of pharmaceutical industry development plans or action plans, and issued a number of specific measures to encourage innovation in key areas of research, comprehensively promote the high-quality development of the medical device industry, effectively maintain the high level of safety of medical devices, and establish a new production relationship suitable for new quality productivity.
In May 2015, The State Council issued the "Made in China 2025", which has always taken innovation as the core position of manufacturing development. In October 2016, the CPC Central Committee and The State Council issued the Outline of the Healthy China 2030 Plan to improve the government-industry-university-research collaborative innovation system and promote pharmaceutical innovation and transformation and upgrading. In August 2023, The State Council reviewed and adopted the Action Plan for High-quality Development of the Pharmaceutical Industry (2023~2025) and the Action Plan for high-quality Development of the Medical equipment Industry (2023~2025), focusing on improving the resilience and modernization level of the pharmaceutical industry and medical equipment industry, and speeding up the shortcomings of China's high-end medical equipment.
The State Food and Drug Administration focuses on the overall planning of high-quality development and high level of safety, in accordance with the principle of "advance intervention, one enterprise, one policy, full guidance, research and review linkage", plans to further deepen the policy measures of medical device regulatory reform, continues to deepen the reform of the review and approval system, and gives priority to the review and approval of innovative medical devices. Actively promote the development and listing of innovative medical devices and high-end medical devices, accelerate the cultivation and development of new quality productivity of medical devices, and promote China's development from a large country to a powerful country.
02
International policy introduction to encourage medical device innovation
The United States, the European Union, Japan and other countries maintain a leading edge in the field of global medical device research and development, the reason is to create a good policy environment for the innovation and development of medical devices, timely release of measures to encourage medical device regulatory innovation, and drive their biomedical scientific and technological achievements continue to be transformed into medical products that protect and promote public health.
2.1 U.S. policies to encourage medical device innovation
As the world's largest medical device market, scientific and technological progress and innovation contribute as much as 90% to the gross domestic product (GDP) of the United States [1], which is one of the main drivers of economic growth in the United States. In December 2016, the U.S. Congress passed the 21st Century Cures Act, which provides the Food and Drug Administration, The FDA's Innovation Program provides $500 million [2] to reform the premarket approval process for drugs and medical devices to accelerate the review and approval process while ensuring safety and efficacy, so that patients can access innovative drugs and medical devices as quickly as possible.
To promote innovation in the medical device field and accelerate the process to market, the FDA has continuously refined the De Novo Program and implemented the Breakthrough Devices Program. BDP, the Safer Technologies Program (STeP), and Predetermined Change Control Plans (PCCP). Together, these procedures and mechanisms constitute a comprehensive framework designed to provide a customized review path for medical devices with different risk levels and levels of innovation.
In 1997, the FDA's Center for Device and Radiological Health (CDRH) established the De Novo program, To provide a classification and product registration channel for low - and medium-risk medical devices that have no substantial equivalent due to their innovation. Since then, the DeNovo process has been continuously improved by simplifying data requirements, optimizing the classification process, and shortening the approval time. To date, 422 innovative medical devices have been marketed through the De Novo process [3].
CDRH launched BDP in 2018 to replace the prior priority approval process and accelerated approval channel to provide support for accelerated market review services for medical devices that treat life-threatening and irreversible aging diseases. As a complementary pathway to BDP, for medical devices that are used to treat less serious diseases but are innovative in terms of safety, the FDA issued STeP in September 2019 to encourage the marketing of medical devices that are reasonably expected to significantly improve the safety of existing treatments or diagnostics.
In 2023, the CDRH issued a PCCP on artificial intelligence and machine learning medical devices, which allows the production process of such medical devices to undergo predetermined minor changes after the product is launched, without having to go through a complete approval process each time, in order to quickly adapt to technological developments and market needs.
2.2 EU policy to encourage innovation in medical devices
There are about 25,000 medical device manufacturers in the EU, employing 575,000 people, 95% of which are small and medium-sized enterprises [4]. Through transnational cooperation, EU member states jointly develop new technologies and new products, realize resource sharing and complementary advantages, and rely on regional superior resources to establish differentiated medical device development clusters. For example, Switzerland has been rated as the world's most innovative country for many years in a row, and it has established six medical device innovation industrial parks, gathering a large number of scientific research institutions and innovative enterprises, forming a medical device innovation ecosystem that closely integrates production, university and research [5].
The EU has implemented the "Horizon 2020" major scientific research framework program from 2014 to 2020. The EU SME Innovation Program is an important part of Horizon 2020, which is directly funded by the government to support smes engaged in technological innovation. Its main purpose is to support smes with breakthrough innovative ideas and provide them with the opportunity to industrialize their research results to create new markets or promote existing markets. The top 30 beneficiaries of this program are all enterprises in the fields of biomedicine and medical devices, and their research directions cover subdivisions such as genetic testing, innovative drugs, and high-end medical devices [6]. In addition, EU countries have also issued preferential policies such as tax credits with their own characteristics, which further incentivise the innovation investment of enterprises, which makes EU medical device manufacturers mostly small and micro enterprises.
2.3 Japan's policy to encourage medical device innovation
Japan is another major medical device manufacturing place after the United States and Europe, and the output of patented technology is second only to the United States and China [7]. Japan is known for its high-quality, high-precision manufacturing processes, which contribute to the production of sophisticated medical device products, such as medical imaging medical devices. Japanese medical device innovation mainly comes from the cooperation between industry and academia and research institutions. This cooperation mode helps medical device enterprises to quickly obtain the latest scientific research results and technical support, and improve research and development efficiency and innovation level.
In order to promote the simultaneous listing of innovative medical devices in Japan and abroad, the Japanese Ministry of Health, Labor and Welfare has issued a series of policy measures such as the Action Plan for Accelerating Medical Device Review, the Cooperation Plan for Rapid Medical Device Review, the Conditional Early Approval System for Innovative Medical Devices [8], including clarifying the standard review period for the priority review of innovative medical devices for 10 months. Allow a part of Class II and III medical devices to be listed through third-party certification, increase the number of reviewers, and conditionally approve innovative medical devices used to treat rare diseases or diseases with a small number of clinical trial subjects to speed up the listing process of innovative medical devices in Japan.
The Japanese government has revised the Basic Law on Small and Medium-sized Enterprises (smes) several times since it was issued in 1963, the most recent revision being in 2022, and has issued an updated White Paper on smes for 62 consecutive years [9], further emphasizing the improvement of smes' independent innovation capabilities, enhancement of international competitiveness, and promotion of digital transformation and environmental sustainability. These revisions and statistics reflect the adjustment and upgrading of the Japanese government's support policies for smes in the context of globalization and digitalization. The Japanese government clearly gives financial support to small and medium-sized enterprises using their own technology to develop medical devices in the form of laws; Encourage small and medium-sized enterprises to jointly develop medical devices with universities and medical institutions, and increase training in the registration and evaluation process, so as to strengthen the verification of the efficacy of small and medium-sized enterprises and the grasp of the medical market demand.
03
The situation and challenge of innovative medical devices in China
3.1 Encouragement and support mechanism to be optimized
First, the medical device innovation coordination mechanism needs to be further improved. At this stage, the coordination between medical device enterprises, universities and platforms is not enough, the policy mechanism for efficient innovation has not been established, and the school-enterprise collaborative innovation ecology has not yet formed. Second, the supply of compound innovative talents is insufficient. The proportion of advanced and sophisticated talents who can play a leading role in major scientific research projects and key disciplines in medical devices is not high enough, especially in core technology fields such as artificial intelligence, biomaterials, and high-end equipment. Third, the policy resource coordination mechanism needs to be further optimized. At present, the relevant departments of the state have issued a series of policies to service innovation and encourage innovation, but the advantages of policy resources need to be further transformed into the advantages of industrial innovation, and while attaching importance to the formulation and implementation of policies, it is also necessary to attach importance to the cohesion and supporting between policies.
3.2 The diversification of innovation direction needs to be strengthened
At present, China's innovative medical devices are mainly concentrated in cardiovascular disease treatment, tumor treatment, ultrasound diagnosis and other fields, the overall innovation field research direction appears centralized, homogenization phenomenon, innovative medical device industry layout distribution is uneven, and there is a low level of duplication trend. Although there are breakthroughs in high value-added products, they are still dominated by imitation of foreign products. There are industrial gaps in many emerging key areas, such as single application scenarios in the field of medical artificial intelligence and low industry penetration. Surgical robots are mostly used in orthopedics and other fields with relatively low complexity, while there are no mature products on the market in neurosurgery and vascular intervention fields with complex surgical procedures and high degree of refinement. In the fields of whole genome detection, gene therapy, cell therapy, cell 3D printing technology, although the key technologies have been in the stage of rapid development, but due to many factors such as high treatment costs and difficulties in long-term safety and effectiveness evaluation of products, innovative products in related fields are still in the research and development stage.
3.3 Interdisciplinary and cross-industry collaboration in the innovative medical device industry needs to be improved
There is a close relationship between the innovative medical device industry and its upstream and downstream industries. On the basis of ensuring product quality and for the purpose of reducing production costs, how to link upstream and downstream industries and choose the best cooperation mode is an important issue facing the innovation and development of the medical device industry. In addition, interdisciplinary integration is also an important way to promote biomedical technology innovation and transform scientific research achievements into innovative medical devices. However, the problem of interdisciplinary and cross-industry collaboration is not high, which is also one of the challenges facing the innovation and development of medical devices in China.
3.4 The combination of scientific innovation and industrial innovation needs to be strengthened
The connection between China's medical device industry and scientific and technological innovation and development and clinical actual needs is not close enough, resulting in a lag effect between scientific innovation and industrial innovation in the field of medical devices, and the overall technology conversion rate of the industry is low. At present, a virtuous circle of "basic research-invention patents-applied research-industrialization-commercial profits-basic research" has not been formed for the transformation of scientific and technological innovation achievements. The research direction of universities, research institutes and other research institutions focuses on basic research and frontier technology, and pays insufficient attention to the actual market demand and technical difficulties in industrial production. The key scientific problems solved by the research work do not include the key technical problems in the practical application of medical device products.
3.5 The regulatory mechanism for innovative medical devices needs to be further improved and optimized
Innovative medical devices are market circulation products with the dual attributes of science and technology and medical treatment. Due to its scientific and technological attributes, innovative medical devices are facing fierce international competition at this stage, and the information integration before and after listing is insufficient, with large investment amount, long recovery cycle, large risk and uncertain investment returns. Due to its medical attributes, the implementation and changes of policies such as the "three doctors" linkage will have an impact on the listing process, market access, and medical insurance payment of innovative medical devices. At present, the listing path of innovative medical devices in China needs to be further broadened, and the supervision method of the whole life cycle needs to be personalized.
04
Thoughts on the development path of innovative medical devices
4.1 Strengthen macro policy guidance to achieve "four-chain integration"
In the face of medical device innovation with large investment, high risk and long return cycle, it is more necessary to "four-chain integration" as the main engine to achieve high-quality development of the medical device industry, to enable industrial transformation and upgrading with innovation chain, to explore the future direction of the industry with industrial chain layout, and to improve the capital chain to promote the benign interaction between finance, technology and industry. The construction of talent chain provides intellectual support for the above three chains to play a role.
First, we need to strengthen the deep integration of the innovation chain and the capital chain. National financial departments need to play a good "combination of capital chain" to provide a strong guarantee for the innovation chain; Make a good "first hand chess" in the innovation chain, open up new market areas and attract more capital inflows. According to the complexity of the types of scientific and technological innovation and the maturity of the research and development cycle, it is necessary to match the types of capital investment with different levels of risk bearing. For example, for the innovation of "bottleneck" technical problems such as general technology and common technology, taking into account their quasi-public product attributes, policy tools can be used to give play to the guiding role of government funds, and relevant scientific and technological innovation research and development funds can be established. For industrial innovation that is still in the nascent stage, due to strong market uncertainty and no scale effect has been formed, the scale of small and micro financial bonds can be gradually expanded, or the venture capital of the capital market can be used to drive and incubate. For more mature industrial innovation, further improve the financing docking system, pilot investment and loan linkage innovation business, and promote traditional financial institutions such as banks, insurance and securities brokerages to participate in scientific and technological innovation investment [10].
Second, we need to strengthen the deep integration of innovation and industrial chains. The national science and technology department can lay out the innovation chain around the pain points and difficulties of the industrial chain, cultivate a number of cutting-edge, breakthrough and leading medical device innovation clusters nationwide, accurately locate the leading industries of the cluster, promote cluster collaboration and interconnection, enhance professional supporting capabilities, and strengthen the environment construction within the innovation cluster. Build a regional innovation ecology composed of strong interaction of innovation subjects. Efforts should be made to build "incubators" and Spaces for mass innovation within the innovation cluster, promote cooperation among innovation subjects within the cluster, and accelerate the transformation of industry-university-research results. At the same time, efforts should be made to create a public exchange space designed to help new enterprises grow, and promote the deep integration of innovation chain and industrial chain in the physical platform. The medical device innovation cluster attracts more high-quality enterprises from upstream and downstream of the industrial chain, gives play to the industrial agglomeration effect, and promotes the development of the industry in the direction of scale, specialization and high-end.
Third, we need to strengthen the deep integration of innovation chain and talent chain. The talent chain provides human resources for the innovation chain, and its structure is continuously optimized and its level is continuously upgraded, which can play a powerful positive role. In terms of personnel training, the national education department can focus on the characteristics of the medical device industry covering a wide range of specialties and involving many disciplines, deepen the supply side reform of university disciplines and specialties as a starting point, explore the implementation of an effective mechanism for universities, research institutes and enterprises to jointly train high-quality compound talents, accelerate the promotion of industry-university-research cooperation education, and improve the suitability of professional and technical personnel and the medical device industry. Build a scientific and modern personnel training system [11]. In terms of talent introduction, for the advanced fields of the medical device industry, the talents selected in the national overseas high-level talent introduction program, national leading talents and other projects and (or) the team of the establishment of high-end medical device enterprises, give policy support, tax incentives, financial support, and constantly optimize the evaluation mechanism of scientific and technological innovation achievements, reflect the value of talents, stimulate the enthusiasm of talents, Thus, the talent chain feeds the innovation chain, promotes the industrial chain, and connects the capital chain.
4.2 Strengthen the implementation of policies and clarify the direction of efforts
Break through the communication barriers in all aspects of production, university, research and medicine, guide production enterprises to develop new technologies, constantly standardize clinical research guidance, better and faster meet the requirements of clinical transformation of products, support clinical institutions, scientific research departments, academic groups, production enterprises and other coordination to establish a joint cooperation platform, and build a virtuous cycle of development mechanism dominated by the transformation of scientific and technological innovation results. Encourage social capital to build various industrial service platforms, check the lack of government funds, focus on building service resources that are difficult to cover by social capital, build a benign closed-loop industrial innovation ecology, and stimulate the vitality of high-quality full-capacity system results transformation platforms.
Build a national medical device innovation and transformation information management platform to achieve accurate development and large-scale development of innovative medical device products. Improve the automation, digitalization and intelligence level of innovative medical device production equipment, and develop information production equipment based on artificial intelligence. The deep integration of technology breakthrough, innovation factor allocation and industry, based on basic scientific principles and innovation theories, integrates multi-source heterogeneous data such as health wearable devices, Internet medical care, and medical insurance to realize the interconnection of health data and active health product data, and further improves the innovation ability and efficiency of the medical device industry.
We will give full play to the leading and supporting role of leading enterprises, guide large enterprises to open up scientific and technological innovation, supply chain, financial services and other resources to the upstream and downstream of the industrial chain, and promote integration and innovation with small and medium-sized enterprises. Take production enterprises as the leading role to promote the professional cooperation of the upstream and downstream industrial chain of medical devices, and promote interdisciplinary and cross-industry technical exchanges. Support leading enterprises to lead the formation of innovation consortions, and undertake the construction of innovation platforms such as industrial innovation centers, engineering technology research centers, and manufacturing innovation centers. We will encourage innovation and entrepreneurship in the field of biotechnology and support the development of micro, small and medium-sized enterprises. Coordinate resources to promote the break point and blocking problem between scientific and technological innovation and industrial development, and promote the solution of the "stuck neck" problem in the high-end medical device industry.
At present, the state has issued a series of support policies and set up support funds to encourage the development of innovative medical devices in China, such as the Ministry of Industry and Information Technology proposed by 2030 county-level hospitals domestic high-end medical devices share of 95% of the industrial development goal [12], which has brought huge development opportunities and space for industrial development. With the layers of support policy landing, through the combination of independent innovation and technology introduction and innovation, China's medical device industry is gradually out of low-level duplication, gradually to high-quality development, in high-end imaging equipment, treatment equipment, in vitro diagnostic products and implant intervention products and other subdivisions have gradually realized the key core technology research. The independent and controllable industrial system has taken shape, the industrial chain from raw materials, core components to the whole machine manufacturing has been continuously improved, and the domestic alternative development trend of high-end innovative medical devices has accelerated.
n key areas with large scale, deep technology and wide influence, such as artificial intelligence, high-end imaging equipment, new biomedical materials, and advanced therapeutic technology, production enterprises are encouraged to deeply cultivate subdivided fields, deepen development advantages, achieve key technological breakthroughs, help develop new quality productivity, and achieve high-quality development of the medical device industry. The industrial technology direction of the development of innovative medical devices mainly includes: high-end imaging equipment represented by 7T whole-body magnetic resonance imaging system; Medical robots represented by endoscopic surgery robots and exoskeleton robots; High-end monitoring and life support equipment represented by extracorporeal membrane oxygenator (ECMO); Advanced treatment technology represented by proton heavy ion integrated treatment system and digital therapy; New biomedical materials represented by recombinant collagen, degradable materials, tissue and organ induced regeneration and repair materials; Ai medical device software represented by AI-assisted decision/diagnostic analysis software; Health management equipment represented by medical grade wearable health monitoring equipment and community self-service health testing equipment; Molecular diagnostic products for disease screening and precision medicine; Brain science and technology represented by brain computer interface.
Strengthening the deep integration of new technologies in the above fields and the medical device industry, focusing on the source of innovation in the forefront of science and technology, focusing on original research including core technologies, and realizing the "bend overtaking" of innovative medical device development will bring new changes to the development of the medical device industry, and may give birth to new formats in the field of health industry.
4.3 Improve the regulatory mechanism for innovative medical devices, and innovate review approaches and tools
Innovative medical devices integrate advanced technology and professional scientific research. In the evaluation of the safety and effectiveness of innovative medical devices, it is necessary to use innovative regulatory methods such as real-world evidence, review focus forward, penetrating supervision, and modern information technologies such as "Internet +", artificial intelligence, and large models. Improve the mechanism for supporting the development of innovative medical devices, deepen the reform of the whole process of medical device supervision, restructure or cooperate with regulatory relations, mobilize the resources of regulatory authorities, enterprises, hospitals, research and development institutions, etc., and transform the existing top-down directive supervision mode into multi-level and top-down linkage supervision [13]. Break the institutional barriers that hinder the flow of production factors and industrial development, and promote scientific and efficient supervision. Strengthen the integration of the reform system, pay attention to coordinated promotion, so that all aspects of innovation initiatives cooperate with each other and complement each other, and maximize the overall benefit of innovative medical devices.
Strengthen the linkage of research and review of innovative medical devices, focus on medical devices that treat seriously life-threatening diseases without effective treatment means, make up for the shortcomings of high-end medical equipment, solve the problem of domestic substitution, further strengthen the supply and guarantee of technical review and consulting services, and give full play to the role of artificial intelligence, biological materials, high-end medical equipment innovation cooperation platform. With the medical device Technical evaluation Center of the State Drug Administration as the main force, the joint medical device technical evaluation and inspection branch center of the Yangtze River Delta and the Greater Bay Area branch center, radiating and driving a total of 11 innovation service stations in Zhejiang, Jiangsu, Guangdong, Shanghai, Sichuan, Jilin, Fujian, Shandong, Beijing, Hubei, Hebei, through the communication and exchange of key technical issues between the review institutions and the research and development team. To guide the whole development process of innovative medical devices such as product preclinical research and clinical trials, product design optimization and industrialization.
On the basis of the relevant policies of the State Food and Drug Administration to encourage innovative medical devices, referring to the United States De Novo program and a series of projects to accelerate the market of innovative medical devices, to refine the category of innovative medical devices, optimize the review process and the allocation of review resources, and provide unique registration review services for innovative medical devices with different risk levels. By establishing international consensus on technical review, promoting joint review among national regulatory agencies, and simplifying review data requirements and process requirements, innovative medical devices will be included in the key varieties of Common Evaluation Reliance Practice (CERP) [14]. Help bring innovative medical devices to market.
Innovative medical device market paths have the advantage of adapting to real-world data applications. Real-world data application is one of the important tools to improve the level of medical device regulatory science and regulatory decision-making ability, encourage the conditional approval of the way to balance the data collected before the market of innovative medical devices and the data expected to be collected after the market, comprehensive assessment of the risk and benefit of the product, and evaluate its safety and effectiveness in a way that is closer to the clinical use scenario.
Continue to pay attention to the international progress of regulatory science research, and contribute knowledge and technical reserves to regulatory innovation. Improve the transformation mechanism for the development of regulatory science to help innovative medical devices, innovate the use of 5G, artificial intelligence, Internet of things, cloud technology, big data, blockchain and other "new infrastructure" technologies to help innovative medical devices real-world data research, and promote the extension of supervision to the front end of the research and development and transformation stage.
Dynamic grasp of high-risk innovative medical device research and development, investment and industrial distribution, understand the trend of medical device new product research and development, strengthen the source supervision, process strict control, comprehensive strengthen clinical trial supervision, quality management system supervision, not only to increase the support for innovative medical device research and development, but also to force enterprises to improve the quality of research and development, improve quality management capabilities. Dig deep into the needs of industrial development, strengthen the ability to accelerate smart supervision, formulate and release the quality of review and registration quality improvement action plans for key areas and key projects.
05
knot
Encourage the development of innovative medical devices, cultivate new momentum for the development of new quality productivity, make good use of the "four-chain integration" methodology, strengthen macro policy guidance, strengthen policy implementation, and improve the listing path of innovative medical devices. To "new", the formation of a new production relationship that is compatible with the development requirements of new quality productivity, so that innovative medical devices are more and more widely used in medical fields such as diagnosis, treatment, rehabilitation, and so on, so that the public can share more opportunities and dividends of new quality productivity.
First Author Profile
Gao Guobiao graduated from School of Pharmacy, Beijing Medical University with a Bachelor of Science degree. He is currently secretary of the Party Committee and deputy director of the Medical Device Technical Review Center of the National Medical Products Administration, and deputy leader of the clinical real-world data application pilot leading group of Boao Lecheng International Medical Tourism Pilot Zone in Hainan. Since 1998, he has worked for the Department of Drug Safety Supervision, the Department of Medical Device Supervision and the Department of Medical Device Registration Management of the State Drug Regulatory Department, and served as the vice Chairman of the Global Medical Device Regulatory Coordination Committee (GHWP) from 2017 to 2023. He has been engaged in adverse drug reaction monitoring and evaluation, drug classification management, national essential drug system and catalogue, medical device product registration, standards, classification, naming, coding, adverse event monitoring and clinical trial management
About the corresponding author
Wang Yingjun, Academician of Chinese Academy of Engineering, "Fellow" of International Academy of Biomaterials Science and Engineering. The President of Guangdong Institute of China Engineering Science and Technology Development Strategy, the President of Guangdong Institute of New Biomaterials and High-end Medical Devices, the president of the College of Global Medical Device Regulatory Coordination (Guangzhou), and the Chairman of the Technical Committee of Medical Device Classification of the State Drug Administration; He is currently a professor of South China University of Technology, director of the National Human Tissue Function Reconstruction Engineering Technology Research Center, and director of the Medical Device Regulatory Scientific Research Base of the State Drug Administration of South China University of Technology. Major: Biomaterials Science and Engineering
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