Text / From the speech of Xu Jinghe, Deputy Director of the State Drug Administration, at the medical device economic information conference of the Southern Institute on 25th September
Medical devices are an important material basis for developing people’s health and improving people’s health. The development of medical device industry is related to the implementation of the strategy of Healthy China and Manufacturing Powerful Country. The Party Central Committee and the State Council attach great importance to the innovative and high-quality development of the medical device industry. General Secretary Xi Jinping has repeatedly stressed the need to accelerate to make up for the short board of China’s high-end medical equipment, accelerate the key core technology research, break through the bottlenecks of technology and equipment, and achieve independent control of high-end medical equipment. To focus on key core technology research, accelerate the solution of a number of drugs, medical equipment, medical equipment, vaccines and other areas of the “neck” problem. To strengthen basic research and scientific and technological innovation capacity building, the lifeblood of the development of the biomedical industry firmly in our own hands.
In recent years, the State Drug Administration has adhered to Xi Jinping’s thought of socialism with Chinese characteristics in the new era as the fundamental guideline, taken the protection and promotion of public health as the noble mission, accelerated the leap from a big country of making devices to a strong country of making devices as the development goal, taken scientific, rule of law, internationalisation and modernisation as the development path, adhered to the people’s supremacy and the supremacy of life, and more consciously integrated the cause of medical device regulation into the work of the Party and the country. We will be more conscious of integrating the cause of medical device regulation into the work of the Party and the State, promote the construction of the rule of law for the regulation of medical devices, implement the scientific action plan for China’s drug regulation more actively, deepen the reform of the review and approval system for medical devices more resolutely, and participate in the international exchanges and co-operation of the regulation of medical devices in a more in-depth manner, so as to boost the high-quality development of the industry innovation with scientific regulation and modern governance, and to safeguard the health rights and interests of the general public.
Strong industry calls for strong regulation, and strong regulation creates strong industry. In the face of the new era of people’s increasing concern for happiness and health, and the new development pattern of domestic and international double cycle, China’s medical device industry has been reforming and innovating, marching forward dream by dream, and has realised the development from scratch, from small to big, from weak to strong, and has now entered the new development stage of “running alongside, parallel running, leading” and co-existing. At present, China’s medical device industry presents the following characteristics:
Firstly, the scale of industry is growing day by day. In recent years, China’s medical device industry has been developing rapidly, with more than 32,000 manufacturing enterprises and more than 1,278,000 operating enterprises.2022, China’s medical device industry-wide revenue exceeded 1.3 trillion yuan, an increase of 12 per cent year-on-year, which is significantly higher than the overall growth rate of China’s pharmaceutical industry and the growth rate of the global medical device industry. According to the Southern Institute of Pharmaceutical Economics of the State Drug Administration, China’s medical device revenue will exceed 200 billion U.S. dollars in 2023, and the proportion of the global medical device market will reach 28.5%.
Secondly, the industrial pattern is becoming clearer. The rapid development of industrial clusters, industrial agglomeration and industrial transfer in parallel, the formation of industrial clusters scale and distinctive features. Bohai Rim, Yangtze River Delta and Guangdong, Hong Kong and Macao Bay Area as the traditional three major clusters continue to develop at a high speed, some high-tech development zones, economic and technological development zones and other high-tech industry clusters are booming, forming regional industry clusters with outstanding specialisation in niche fields. As the midstream of the industry chain, the expansion of the scale of the medical device industry drives the development of the whole industry chain.
Third, the level of technology is increasingly upgraded. In recent years, China has not only accelerated to make up for the bottlenecks and short boards in the fields of basic components, basic software, basic materials and basic technology, but also reaped remarkable results in the improvement of product performance and quality of high-end medical equipment, breaking through a number of key technologies of core components such as superconducting magnets, electron accelerators, RF/spectrometers, etc., and the key technologies of proton and carbon ion therapy system, orthopedic surgical robots, third-generation artificial heart, focused Focused Ultrasound Therapy System, Gene Sequencing System, etc. are close to or have reached the international advanced level.
Fourthly, the innovation ability of the industry is accelerating day by day. In recent years, the State Drug Administration to encourage medical device technology innovation policy continues to force. Since this year, innovative products have continued to maintain the momentum of rapid growth, and so far 41 innovative products have been approved for listing. Some innovative products, such as brain pacemaker, won the first prize of national scientific and technological progress.
Fifth, the quality management system is becoming more and more perfect. In recent years, with the steady progress of the industry’s quality management system demonstration construction, supervision and rectification efforts continue to increase, the main responsibility of enterprises to strengthen the implementation of the quality management system level of the medical device industry continues to improve.
Sixth, the international influence is expanding. In recent years, the international influence of Chinese medical device enterprises has been expanding. More and more Chinese enterprises with advanced technology, compliant operation and sound quality have implemented the strategy of exporting their products to the sea and gradually showed their international influence. According to the list of top 100 global medical device manufacturers in 2022 released by the authoritative website of medical device industry, 12 Chinese companies have successfully entered the list.
The “Healthy China 2030″ programme states that health is a necessary requirement for the comprehensive development of human beings and a basic condition for economic and social development. As an important means to protect people’s health, medical devices play an increasingly important role in the fields of prevention, diagnosis and treatment. From the urgent needs of the country and long-term demand, medical device industry is a key field that needs to focus on advantageous resources, and it is a strategic emerging industry with strong growth, relevance and impetus. Comprehensive research and judgement, at present, China’s medical device industry is still in the “golden development period”. Under the continuous support and empowerment of informatisation, digitisation and intelligence, many new changes will emerge in various segments and tracks of medical devices. For example, the new generation of medical imaging will accelerate the development of intelligent, remote, miniaturised, rapid, accurate, multi-modal fusion, diagnosis and treatment integration, and continue to steadily improve the methodology and performance of genetic testing, concomitant diagnosis of tumours and early diagnosis, tuberculosis prevention and diagnosis, and detection of emerging pathogens. Plant interventional device technology upgrade space is broad, innovation and development of new implantable cardiac pacemakers, neurostimulators and other products, need to pay attention to the development of tissue regeneration and repair function of bioactive composite materials research and development and transformation, and to promote the application of advanced materials, tissue engineering, 3D printing and other technologies.
First, improve the regulatory system, strengthen the foundation of development. 2021 revised Regulations for the Supervision and Administration of Medical Devices, the rule of law to consolidate and deepen the achievements of the reform of the review and approval system of medical devices, the comprehensive establishment of the medical device registrant system, the clinical evaluation of the requirements of the international standards, the implementation of the record system for clinical trial organisations, the implementation of the clinical trial project implied permission system, allowing enterprises to carry out product self-testing in accordance with the law. In addition, a conditional approval system and an expanded clinical trial system have been established to give priority to the review and approval of innovative medical devices and support the clinical promotion and use of innovative products. Up to now, the whole life cycle quality and safety management system of medical devices has been formed with the “Regulations for the Supervision and Administration of Medical Devices” as the core, supported by 14 supporting regulations, more than 140 normative documents, more than 600 guiding principles for registration and technical review, and more than 760 technical review points, which provides a strong rule of law for the innovative and high-quality development of the medical device industry.
Secondly, the planning of strategic priorities, navigation of the development direction. 2021, the State Drug Administration and a number of departments jointly issued the “14th Five-Year Plan” for national drug safety and the promotion of high-quality development, clear by the end of the “14th Five-Year Plan” period, the overall drug regulatory capacity close to the international advanced level, drug safety and security level of sustainable development of the medical device industry. By the end of the “14th Five-Year Plan” period, the overall drug regulatory capacity will be close to the international advanced level, the level of drug safety and security will continue to improve, and the people will be more satisfied with and more at ease with the quality and safety of drugs. The regulatory environment to support the high-quality development of the industry will be more optimised, the reform of the review and approval system will continue to be deepened, a number of clinically-needed innovative drugs will be approved, the listing of clinically-valuable innovative drugs will be accelerated, and globally-innovative drugs and innovative medical devices applied for in China will be listed in the territory as soon as possible. The State Drug Administration, together with the Ministry of Industry and Information Technology, the Ministry of Health and other departments, jointly issued the “14th Five-Year Plan” for the development of the medical equipment industry, making it clear that by 2025, the level of China’s medical equipment industry will be significantly improved in terms of the advanced foundation and modernisation of the industrial chain, the mainstream medical equipment will be basically effectively supplied, and the level of high-end medical equipment performance and quality will be significantly improved, initially forming the basis for public health and medical equipment. The performance and quality level of high-end medical equipment products will be significantly improved, and the comprehensive support capacity for public health and medical and healthcare needs will be initially formed. In recent years, the State Drug Administration and relevant departments have jointly issued the Action Plan for Concentrated Attack on High-end Medical Equipment, the Implementation Plan for Robotics+ Application Action, and the Guiding Opinions on Accelerating the Innovative Development of the Medical Device Industry, which have strengthened the top-level design and assisted in the policy support to open a broader path of development for the innovative and high-quality development of the medical device industry. A broader development path.
Thirdly, integrating governance resources and gathering development power. In recent years, the State Drug Administration has strengthened cooperation with many departments, and has set up an artificial intelligence medical device innovation cooperation platform and a biomaterials innovation cooperation platform, to promote the synergistic efforts of industry, academia, research, use and management, and to gather the strength of all parties to form a surging kinetic energy for the high-quality development of industrial innovation. The State Drug Administration has jointly carried out with the Ministry of Industry and Information Technology (MIIT) the work of unveiling the list of artificial intelligence medical devices and biomaterials, focusing on the forefront of technological development, laying out in advance, selecting high-end medical devices, and focusing on the support for the high-quality development of medical device innovation to gather power and empowerment. Actively support the Ministry of Science and Technology special research and development of new coronavirus detection products, Ministry of Industry and Information Technology special extracorporeal lung membrane oxygenation machine (ECMO) project product registration. The Yangtze River Delta, the Bay Area, two medical device review and inspection sub-centre is running steadily, to better serve the national regional major strategies, and better serve the medical device industry innovation and high-quality development.
Fourth, deepen the approval reform and innovative development mechanism. In recent years, the State Drug Administration has continued to deepen the reform of the review and approval system, in accordance with the “Special Review Procedures for Innovative Medical Devices” and “Priority Approval Procedures for Medical Devices”, and give priority to review and approval of high-end medical devices whose core technologies have patents for invention in China, and whose products have the first domestic invention of the main working principle/mechanism of the product, and whose products have significant value of clinical application and are urgently needed in clinic, and to allow these products to be “queuing up separately, running all the way”. Up to now, 230 innovative medical devices such as domestic brain pacemaker, carbon ion therapy system, proton therapy system, 5.0T magnetic resonance imaging system, panoramic dynamic PET/CT, third-generation artificial heart, artificial blood vessels and other innovative medical devices have been approved and listed on the market, realising the breakthrough of domestic high-end medical devices. In recent years, the Medical Device Technical Review Centre has continuously innovated review initiatives and established a working mechanism to shift the focus of medical device technical review to the product development stage, focusing on the products that may achieve breakthroughs in key technologies, key materials and core components, and have independent intellectual property rights, such as ECMO system, proton carbon ion therapy system and ventricular assist system and other high-end medical devices, etc., and intervene in advance to guide and speed up The key core technology research and development, in order to lead the way, to promote China’s high-end medical devices to achieve a major breakthrough. At present, the State Drug Administration has set up nine medical device innovation service stations to support local medical device industry innovation and high-quality development.
Fifthly, developing regulatory science to enhance the level of development.In 2019, the State Drug Administration launched China’s Drug Regulatory Science Action Plan to adapt to the new challenges brought by new technologies, materials, processes, products, businesses and modes of operation to the approval and regulation, and to innovate new tools, standards, and methods of regulation, in an effort to make regulation a leader and enabler for the innovative and high-quality development of the industry. Up to now, SDA has recognised 9 medical device regulatory science research bases, 29 key laboratories related to medical device field of SDA, and launched two batches of regulatory science projects. With the increasing depth of regulatory scientific research, new tools, standards and methods are being applied in the review and approval of medical devices and supervision and management, providing scientific and technological support and wisdom support for the development of industrial innovation and high quality.
Sixth, deepen the exchange and cooperation to expand the development space. In recent years, the State Drug Administration to increase international exchanges and cooperation, help the global medical device regulatory convergence, coordination and trust, led the development of four international medical device clinical evaluation management guidelines, led the development of the “medical electrical equipment Part 2-90 high-flow respiratory therapy equipment, basic safety and basic performance” “in vitro diagnostic test system – nucleic acid amplification method for detecting novel Requirements and Recommendations for Coronavirus (SARS-CoV-2)” and other six international standards. At present, the total number of medical device standards in China has reached 1,961, and the degree of consistency with international standards has reached more than 90%. We actively participate in the activities of IMDRF, GHWP and other international organisations to help accelerate the global medical device regulatory convergence, coordination and trust, and to help China’s medical device products to better go global.
General Secretary Xi Jinping has repeatedly stressed that people’s health is an important symbol of national prosperity and national strength; that adherence to innovation has a central place in the overall situation of China’s modernisation; and that high-quality development is a primary task in the comprehensive construction of a modern socialist country. The important symbol, core position and primary task profoundly elaborate the strategic value and prominent position of people’s health, innovation and high-quality development in the construction of socialist modernisation. The report of the 20th Party Congress proposes that we should insist on putting the focus of economic development on the real economy, promoting new industrialisation, accelerating the construction of a strong manufacturing country, a strong quality country, a strong network country, a strong digital China and so on. To promote the integration and cluster development of strategic emerging industries, to build a new generation of information technology, artificial intelligence, biotechnology, new energy, new materials, high-end equipment, green environmental protection and a number of new engines of growth. 25 August, the State Council executive meeting considered and adopted the “Pharmaceutical industry high-quality development action plan (2023-2025)”, “medical equipment industry high-quality development action plan (2023-2025)” and “medical equipment industry high-quality development action plan (2023-2025)”. Development Action Plan (2023-2025) for the Medical Equipment Industry. The meeting emphasised that the pharmaceutical industry and medical equipment industry are the important foundation of health care, and have a bearing on people’s life and health and the overall situation of high-quality development. Efforts should be made to improve the resilience and modernisation of the pharmaceutical industry and medical equipment industry, enhance the supply capacity of high-end medicines, key technologies and raw and auxiliary materials, and accelerate the mending of the short board of high-end medical equipment in China. Implement the major decisions and deployments of the CPC Central Committee and State Council, accelerate the modernisation of China’s medical device regulation, accelerate China’s progress from a large country to a strong country in the manufacture of medical devices, from the regulatory end of medical devices, we will focus on the following aspects of the work:
First, continue to deepen the review and approval system reform, accelerate the pace of innovative medical devices on the market. At present, China’s medical device industry has entered a new era of independent innovation and development mainly from imitation follow-up. The ability to develop medical devices and the ability to review medical devices have become the core elements to measure the global competitiveness of a country and region’s medical devices. Innovation is the first driving force to lead development and the greatest source to promote change. For pre-market surveillance, product is king. We will always adhere to the spirit of science and the spirit of the rule of law, actively adapt to the new needs of global medical device scientific and technological progress and industrial development, actively adapt to the new needs of patients’ clinical treatment, unswervingly deepen the reform of the medical device review and approval system, and unswervingly promote the scientific research on the regulation of medical devices, further improve the review and approval system, optimise the review and approval process, and innovate the review and approval method, so that we can, with better performance. accelerate the pace of innovative medical devices on the market.
Secondly, we will make every effort to promote the construction of the rule of law for medical devices, and accelerate the creation of an upgraded version of the legal system for the regulation of medical devices. The Medical Device Management Law has been included in the legislative planning of the 14th National People’s Congress Standing Committee, which is a significant event in the history of China’s medical device regulation. Law is a tool to create a new life. The process of legislation is the process of deepening the understanding of the law of medical device management, and the process of upgrading the scientific, legal, international and modern level of medical device management. We will adhere to the problem orientation, international vision, reform and innovation, scientific development, and gather more strength to make an all-out effort to create a Medical Devices Management Law with more modern concepts, more harmonious values, more complete systems, and more sound mechanisms, and to further enhance the internationalisation and modernisation of China’s medical devices management. Law is an institutional arrangement for public happiness. We will adhere to scientific, democratic and open legislation, and sincerely welcome all sectors of society to actively participate in the legislative process of the Medical Devices Management Law and endeavour to contribute your wisdom and strength.
Thirdly, we will carry out in-depth actions to consolidate and improve drug safety, and comprehensively strengthen the quality supervision of medical devices throughout their life cycle. Over the years, focusing on risk and responsibility, system and capacity, quality and efficiency, we have continued to carry out the governance of medical device quality and safety, established key varieties, key links, key areas and key regions, and insisted on improving the governance mechanism, enhancing governance capacity, investigating major cases and controlling safety risks. At present, in accordance with the requirements of the drug safety consolidation and enhancement action, around the prominent issues of general concern to the general public, around the shortcomings and weaknesses of the medical device regulatory system and capacity building, in order to comprehensively consolidate the results of the special rectification and actively enhance the effectiveness of the governance of the concentration, practical measures, practical strokes, and seek tangible results, so that the people have a greater sense of access to the people, so that regulators have a greater sense of achievement, and so that the participants have a greater sense of sense of satisfaction.
Fourth, actively promote the construction of quality management system, help medical device industry innovation and high quality development. Product quality is the lifeline of an enterprise. The essence and key point of modern medical device management lies in quality system management. Just as there is no justice without procedural justice, there is no product safety without system safety. In the whole life cycle of medical device quality management process, any small defects may lead to system breakage. Quality system runs normally, the product problem is accidental; quality system runs abnormally, the product has no problem is a gift. In the field of medical devices, it is necessary to carry out the construction of quality management system, to prevent risks with the system, to ensure safety with the system, to strengthen the ability of the system, to seek development with the system. In promoting the construction of medical device quality management system, we hope that the medical device industry association can have a greater commitment and act.
Fifth, actively participate in international exchanges and co-operation, help the global medical device regulatory convergence, coordination and trust. Today’s world is an open world. General Secretary Xi Jinping pointed out that “building a community of human destiny is the future of the peoples of the world.” “At present, the change of the world, the change of the times and the change of history are unfolding in an unprecedented way.” “We need to expand our world vision, gain a deep insight into the trend of human development and progress, respond positively to the universal concerns of people from all countries, contribute to solving the common problems faced by mankind, and draw on and absorb all the outstanding civilisational achievements of mankind with a broad-mindedness that embraces all rivers, so as to promote the building of a better world.” Adapting to the development of economic globalisation and trade liberalisation, we will actively participate in global medical device regulatory exchanges and co-operation with a broader vision, a more positive attitude and a more steady pace, and strive to promote global medical device regulatory convergence, co-ordination and trust, so as to jointly contribute to the global public health in a way that is worthy of this great era.
We will not be far away from the mountains and oceans; we will not be limited by the sun and the moon when we ride on the momentum. The brighter future of China’s medical device industry lies in the future, in the front and under the feet. Let us work together, in accordance with the requirements of the State Drug Administration “to speak politics, strong supervision, ensure safety, promote development and benefit people’s life”, forge ahead, work hard, accelerate the leap from a big country to a strong country in the manufacture of medical devices, and make greater contributions to the protection and promotion of public health.
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Post time: Oct-17-2023