In recent years, China's medical device industry has developed rapidly, with an average compound annual growth rate of 10.54 in the past five years, making it the second largest market for medical devices in the world. In this process, innovative equipment and high-end equipment have been continuously approved, and equipment access and regulatory systems have also been continuously improved.
Today (July 5), the Information Office of the State Council held a series of press conferences on the theme of "the opening of authoritative departments". Jiao Hong, director of the State Drug Administration, introduced the relevant situation of "strengthening drug supervision and effectively ensuring the safety of drug use by the people.
The meeting talked about the review and approval of medical devices, medical device supervision, innovative medical devices, medical device network sales and other industry concerns.
217 Innovative Medical Devices Approved
Medical device innovation into the outbreak period
Jiao Hong, director of the State Drug Administration, pointed out at the meeting that we should adhere to innovation driven and service to support the high-quality development of the pharmaceutical industry. The review and approval system for drugs and medical devices has been promoted in an orderly manner, the review and approval process has been continuously optimized, and a large number of innovative drugs and innovative medical devices have been approved for listing. In recent years, a total of 130 innovative drugs and 217 innovative medical devices have been approved. In the first half of this year alone, 24 innovative drugs and 28 innovative medical devices have been approved for listing.
Jiao Hong said that the State Food and Drug Administration continues to deepen the reform of the review and approval system for drugs and medical devices, and policy dividends related to encouraging innovation are also being continuously released. Through the acceptance volume and examination volume of drugs and medical device products in recent years, including the acceptance volume and review volume in the first half of this year, it is obvious that China's drug and medical device innovation achievements have entered an explosive period.
Encouraging innovation is the core of the reform of the drug and medical device review and approval system. Over the years, we have accelerated and strengthened the formulation and revision of supporting regulations such as the administrative measures for the registration of drugs and medical devices, and continuously released policy dividends. Through the tilt of relevant resources, the market of new drugs with clear clinical value, clinically urgently needed drugs and medical devices has been further increased.
Optimization of domestic substitution, "stuck neck",
Innovative high-end equipment product approval
China's medical device industry is in a stage of rapid development, with official data showing a compound annual growth rate of 10.54 per cent in the past five years. At present, China has become the second largest market for medical devices in the world, and its industrial agglomeration and international competitiveness have been continuously improved.
Xu Jinghe, deputy director of the State Drug Administration, said that in recent years, the State Drug Administration has strengthened top-level design and promoted departmental coordination. The State Food and Drug Administration and various departments jointly issued the "14th Five-Year Plan for National Drug Safety and Promotion of High-Quality Development", clarifying the overall principles, objectives and tasks for promoting the high-quality development of the medical device industry. With the Ministry of Industry and Information Technology, the National Health Commission and other departments jointly issued the "14th Five-Year Plan for the Development of Medical Equipment Industry" and other documents, forming a policy synergy.
It has led the establishment of two technological innovation cooperation platforms for artificial intelligence medical devices and medical biomaterials, accelerated the transformation and application of relevant scientific and technological achievements in the field of medical devices, cooperated with the work of unveiling relevant products, focused on the forefront of scientific and technological development, and laid out in advance.
Strengthen regulatory scientific research and continuously innovate review measures. Initiate the implementation of the China Drug Regulatory Science Action Plan, and continue to develop new tools, new standards, and new methods for medical device supervision around the frontiers of technology and supervision. Establish a working mechanism for technical review to move forward to the product development stage, focusing on high-end medical devices such as ECMO, particle therapy system, ventricular assist system, etc., to intervene in advance guidance, speed up key core technology research, point-to-face, and promote China's high-end medical device breakthrough.
Encourage the listing of innovative medical devices and promote the high-quality development of the industry. In recent years, the State Food and Drug Administration has focused on innovative medical devices, and has successively issued the "Special Review Procedure for Innovative Medical Devices" and "Priority Approval Procedure for Medical Devices", allowing innovative products and clinically urgently needed products to "line up separately and run all the way".
At present, 217 innovative high-end medical device products such as domestic "brain pacemaker", carbon ion therapy system, proton therapy system, magnetic resonance imaging system, panoramic dynamic PET/CT, third-generation artificial heart, artificial blood vessel, etc. have been approved to be put on the market. It has achieved a breakthrough in domestic high-end medical devices and solved the situation that some products are heavily dependent on imports. Most of them have served in clinical diagnosis and treatment and achieved good use results, the level of medical diagnosis and treatment in China has been improved.
It is understood that the 2023 National Medical Device Safety Awareness Week will be held next week, during which a report on the results of innovative medical devices will be held.
Xu Jinghe said that in the next step, the State Food and Drug Administration will continue to track the new situation and new progress of medical device innovation and development, constantly sum up new experiences, explore new laws, launch new measures, and approve more and better innovative high-end medical devices to be listed on the market.
Jiao Hong also pointed out that the next step will continue to consolidate and solidify the results of the reform of the review and approval system. We further intensify our work on R & D innovation for enterprises. For example, we will further optimize the relevant working procedures for the review and approval of conditional listing applications to ensure that the drug review work can be scientific, rigorous, standardized and efficient. At the same time, we will continue to optimize the examination and approval of urgently needed drugs, medical devices, children's drugs, rare disease drugs, domestic substitute products, and "stuck neck" products, promote the focus of the review work to move forward, improve the working mechanism of research and review linkage, further strengthen the formulation of technical guiding principles, and strengthen the guidance and service for enterprise product research and development.
These medical devices are included in the national sampling inspection
Xu Jinghe said that the State Food and Drug Administration attaches great importance to the supervision of centralized procurement of drugs and medical devices, and fully implements the "four strictest" requirements in strict accordance with the principles of risk management, whole-process control, scientific supervision, and social co-governance. we will fully implement the main responsibility of enterprise quality and safety and the territorial responsibility of drug regulatory departments, and strive to serve the overall situation of national centralized procurement and medical reform.
Since the launch of the national centralized procurement work, the State Food and Drug Administration has deployed and carried out special supervision of selected drugs and medical devices in the centralized procurement work every year, realizing the supervision and inspection of production enterprises of selected drugs and medical devices in the national centralized procurement, sampling inspection of products in production, and adverse drug reactions (medical device adverse events) monitoring "three full coverage", this work has also been strongly affirmed by the State Health Insurance Bureau.
The inspection involved nearly 600 drug manufacturers and nearly 170 medical device manufacturers; the product sampling inspection involved 333 drug varieties and 15 medical device varieties, which effectively guaranteed the quality and safety of centralized drug and medical device.
At the same time, we should comprehensively strengthen the implementation of the main responsibility of enterprises and the implementation of local supervision responsibilities. From the perspective of supervision and inspection, supervision and sampling inspection, and monitoring of adverse reactions (adverse events), the quality and safety of drugs and medical devices selected by the state are in good condition.
In the next step, the State Food and Drug Administration will continue to strengthen the supervision of selected products in national centralized procurement, strengthen risk prevention and control, and comprehensively use supervision and inspection, random inspection, adverse reaction (adverse event) monitoring and other means to strengthen early warning, early investigation and early disposal of hidden risks. In terms of medical devices, the national collection of selected products such as vascular stents, artificial joints and orthopaedic spine products shall be managed in the list, and the medical devices selected in the national collection shall be included in the national sampling inspection.
Continuously improve the ability of drug supervision, innovate supervision methods and methods, strengthen intelligent supervision, strengthen the analysis and sharing of data on the supervision information of selected drugs and medical devices, and continuously improve the supervision efficiency through information means to ensure the quality and safety of products.
Strengthen the rectification of illegal behaviors of medical devices
Xu Jinghe said that in June this year, the State Food and Drug Administration deployed a one-and-a-half-year drug safety consolidation and improvement campaign. The consolidation and promotion action mainly includes three aspects:
The first aspect is to comprehensively investigate and resolve hidden risks. One is to ensure drug safety from the source. Strict market access, strengthen acceptance, inspection, inspection, approval and other aspects of work convergence. Urge enterprises to implement the main responsibility of quality and safety, and further enhance the awareness of compliance, the rule of law, risk awareness. The second is to improve the pertinence, targeting and effectiveness of risk investigation. Focus on key products, key links, key objects, key areas, etc., multi-channel multi-dimensional comprehensive investigation of hidden risks. Third, timely disposal of security risks in accordance with the law. For high-risk enterprises that have found many problems in the past, we will increase the frequency of on-site supervision and inspection by means of "four no two direct" and flight inspection, and strengthen the rectification of violations of laws and regulations in key areas such as medical beauty drugs and medical devices.
The second aspect is the high-pressure crackdown on violations of the law. We will continue to intensify the investigation and handling of cases so that those who violate the law and regulations will pay the price they deserve. One is to continue to strengthen the investigation of cases. We will implement the provision of "punishment to the person" for illegal acts, improve the supervision system for listing major cases, comprehensively use the means of exposing typical cases and publicizing the list of serious violations and dishonesty, and implement joint punishment, industry ban and employment ban. The second is to continue to strengthen collaborative linkage. Strengthen the organic linkage of drug regulatory departments at the national, provincial, municipal and county levels to eliminate regulatory blind spots. The third is to strengthen cross-departmental collaborative investigation. In conjunction with the public security organs, the procuratorate and the court organs, we will further improve the execution convergence mechanism, further strengthen the linkage with relevant departments, and establish and improve the inter departmental risk consultation system.
The third aspect is to continuously strengthen the improvement of regulatory capacity. Comprehensively strengthen the capacity building of drug supervision, and vigorously improve the effectiveness of supervision.
Strengthen the management of online sales of equipment
At present, China's drug, medical equipment, cosmetics network sales overall showing a high-speed development trend. Huang Guo, deputy director of the State Drug Administration, said that it is estimated that in 2022, only the network sales of drugs and medical devices have reached 292.4 billion yuan, and it is expected to exceed 350 billion yuan in 2023.
Huang Guo, deputy director of the State Drug Administration, pointed out that in order to improve the convenience of online shopping and the quality and safety of drugs sold online, the State Drug Administration has planned and adopted a series of measures in advance, mainly in the following three aspects:
One is to improve the rule of law. We emphasize that the Internet is not an extra-legal place. In view of the new situation and new problems, we should urgently establish and improve the legal system. Up to now, drugs, medical devices and cosmetics have issued special measures for the supervision and management of online sales, which mainly clarify the legal responsibilities of regulatory departments, operating enterprises and third-party platforms, strengthen the relevant provisions on online sales monitoring, investigation and handling of cases, emphasize the relevant measures of safety risk control, and require strengthening quality management in the whole process of online sales. At present, drug regulatory departments at all levels are strengthening the publicity and implementation of the above-mentioned laws and regulations, continuously improving supporting systems, and urging relevant enterprises to fulfill their legal obligations in accordance with the law.
The second is to strengthen network governance. In view of the concealment and divergence of online sales violations, we have stepped up the establishment of a "network management network" mechanism and explored the adoption of a "fast governance" approach, which is to quickly discover and eliminate possible security risks in online sales. At present, we have implemented full-coverage network monitoring for online sales companies and major third-party platforms, and will continue to strengthen monitoring efforts to improve the targeting, accuracy and timeliness of monitoring.
In response to the outstanding problems discovered, the drug regulatory authorities have successively organized and carried out special rectification of drug online sales, medical device "net clearing action", cosmetics "online net clearing action", etc., promptly investigated and dealt with clues of violations of laws and regulations, and adopted A series of measures such as product removal, network shutdown, and cancellation of filing continue to purify the online market.
The third is to promote co-governance. We strengthen multi-departmental collaboration, and actively promote the linkage with multiple departments such as industry and information technology, Internet information, health care, and market supervision to form a regulatory force; at the same time, we focus on the role of industry associations, establish and improve industry norms, and guide industry self-discipline; we also encourage news media, Consumers, etc. actively participate to build a joint management pattern for the whole society.
Huang Guo also stressed that the third-party platform to implement the platform governance responsibility, to improve the quality of online sales, cultivate a good online sales industry ecology is essential. In particular, large platforms such as Ali, Jingdong, Meituan, Pinduoduo and Little Red Riding Book should take the lead in implementing platform responsibilities, make full use of their own technical and management advantages, strengthen the legal qualification examination and management of the settled merchants, strengthen the cooperation obligations of the platforms in product recall, risk disposal and supervision and inspection, and cooperate with relevant departments to do a good job in relevant work.
According to observations, the State Food and Drug Administration guides drug supervision and management departments at all levels to strengthen the supervision of medical device online sales, relying on the national medical device online sales monitoring platform, strengthen the monitoring of medical device online sales and the handling of illegal clues, and severely crack down on violations of laws and regulations. June 30, just reported 6 medical device network sales of illegal cases of information.
According to the report "Development Status and Trends of China's Medical Device Industry" released by Roland Berger, an international management consulting company, China's medical device market is expected to reach 958.2 billion billion yuan in 2022. In addition, the operating income of Chinese medical device manufacturers above designated size accounts for the proportion of the entire industry. Has exceeded 60%.
In recent years, the R & D investment of domestic head medical device enterprises has continued to grow, and innovative devices and high-end devices have emerged. In the policy support, the vitality of the field of equipment will continue to burst.
