Since the 18th CPC National Congress, the CPC Central Committee with Comrade Xi Jinping at its core has insisted on placing people’s health in the strategic position of priority development, and has made the protection of people’s health an important goal of the Party’s struggle for the people, which has fully demonstrated the people-centered development ideology. The technical review of medical devices closely follows the important exposition of General Secretary Xi Jinping on the construction of a healthy China and the spirit of the important instructions on drug supervision, adheres to the people-centered, protection and promotion of public health of the original mission, with the “four most stringent” requirements as the fundamental guide, deepen the reform, and deepen the promotion of all the work has achieved remarkable results. The work has achieved remarkable results.
Over the years, the State Drug Administration Medical Device Technical Review Center (hereinafter referred to as the Center) in adhering to the innovation-driven development, build and improve the system to encourage innovation; to promote the landing of major national projects, focusing on solving the “neck” problem; scientific and efficient completion of the emergency response to the review, to ensure that the new crown of the epidemic prevention and control, etc. implement a series of initiatives, key varieties of Varieties of the implementation of “early intervention, an enterprise a policy, the whole process of guidance, research and review linkage”, to promote the pharmaceutical industry, a high level of scientific and technological self-reliance and self-reliance, to effectively meet the public with access to, and affordable to the urgent need for new arms, and to effectively safeguard the rights and interests of the general public’s health.
Adhere to the innovation drive
Helping to steadily improve the competitiveness of the industry
The report of the 20th CPC National Congress emphasizes that we must insist on innovation as the first driving force, deeply implement the innovation-driven development strategy, open up new fields and new tracks of development, and continuously shape new momentum and new advantages; accelerate the realization of high-level scientific and technological self-reliance and self-reliance, and oriented by the national strategic needs, gather forces to carry out original and leading scientific and technological research and development, resolutely win the battle of the key core technologies, and accelerate the implementation of a number of strategic global and forward-looking national major scientific and technological projects, as well as the implementation of a series of strategic and comprehensive scientific and technological projects. We will accelerate the implementation of a number of major national scientific and technological projects with strategic and global significance, and enhance the capability of independent innovation.
The report of the 20th CPC National Congress has pointed out the practical direction of encouraging innovation of medical devices under the new situation. In recent years, for China’s medical device science and technology innovation support is still weak, the quality of listed products and the international advanced level of the gap between the actual situation, medical devices to encourage innovation to promote industrial restructuring and technological innovation, improve industrial competitiveness as the goal, benchmarking the international advanced concept of innovation and supervision, long-term planning and gradual implementation of the innovation and development of the situation analysis and research, the transformation of innovative achievements to confirm the needs of innovation priority channel construction and operation and other initiatives, and achieved a number of strategic and forward-looking national major projects to enhance independent innovation ability. The long-term planning and gradual implementation of initiatives such as analyzing and judging the situation of innovation development, confirming the demand for transformation of innovative achievements, and constructing and operating innovation priority channels have achieved remarkable results.
Encouraging the rapid listing of innovative medical devices
In 2014 and 2017, the national drug regulatory authorities successively set up special review channel for innovative medical devices and priority approval channel for medical devices. Since the establishment of the two channels, the Center has earnestly implemented the relevant requirements of the Special Review Procedure for Innovative Medical Devices and the Priority Approval Procedure for Medical Devices, set up the Innovative Review Office and Priority Audit Office, and perfected the review process and system construction of the rapid review channel for medical devices with innovative, high level and urgent clinical needs, so as to promote the entry of innovative and clinically urgently needed medical devices into the rapid review channel. By the end of 2023, 251 innovative medical devices and 138 prioritized medical devices have been fast-tracked to the market through the green channel, including a series of innovative, high-technology and clinically urgent medical devices such as carbon ion therapy system, proton therapy system, artificial heart, surgical robot, extracorporeal membrane oxygenation (ECMO), etc., which effectively fill the gaps in the relevant fields, and better satisfy the people’s need to use high-level medical devices. This has effectively filled the gaps in the relevant fields and better met the people’s need for high-level medical devices.
As the executive department of innovative medical device review and priority review of medical devices, the Center has formulated and gradually optimized the internal operation norms of the two matters, which mainly include refining the review requirements, clarifying the working methods, and unifying the principles of adopting opinions, etc. At the same time, the Center has issued the “Special Innovative Medical Device Review” and the “Special Innovative Medical Device Review”. At the same time, the Center has issued the “Guidelines for Preparation of Declaration Information for Special Review of Innovative Medical Devices”, which clarifies the requirements for the preparation and writing of declaration information for the application of innovative medical devices, and provides specific guidance for applicants and R&D personnel. In order to ensure the smooth implementation of work procedures, the Center has also established communication channels for innovative and priority medical device products, and set up an online consultation platform to promote the efficient and orderly implementation of related work.
Ensure the scientific and fair review and audit To ensure the quality of the work of innovation review and priority review, the Instrument Review Center has established a joint review and audit mechanism, led by the center’s supervisory leadership, the Innovation Review Office and the Priority Review Office to implement. Members of the two offices by the State Drug Administration Division of Medical Device Registration, Instrumentation Review Center, the Chinese Biomedical Engineering Society, the Chinese Society for Biomaterials relevant personnel, in the form of members of the work will be organized in the form of a review and audit meetings, the expert review of the views and related issues for collective research and decision-making.
The effective and scientific utilization of external expert resources helps to further improve the work quality of innovation review and priority review. The expert pool for the technical review of medical devices was officially launched in March 2017, and the Center for Instrumental Review has established a supporting system for the management of external experts to standardize the formation, selection, daily operation and other work of the review expert pool. In terms of the operation of the expert consultation meeting, it has explored the establishment of a random blind selection mechanism for experts, improved the form of the expert consultation meeting, avoided human intervention in the expert review to the greatest extent possible, and guaranteed the fairness, impartiality and scientific effectiveness of the review work. At present, the expert pool is under dynamic management, and in principle, it is divided by the clinical application of Class III medical devices, and 17 expert advisory committees have been set up, and the selection of 5 batches of external experts has been completed, with a total of 2,374 external experts (including 41 academicians), involving 119 specialties and 244 research directions.
Accelerating the Review of Innovative Priority Products For innovative medical devices with independent intellectual property rights, at the international leading level, with significant clinical application value, and medical devices in urgent clinical need, supported by national major special projects and national key R&D programs, the Center has continued to implement the priority review in accordance with the principle of not lowering the standards and moving the services forward. The Center continues to optimize the technical review process of innovative priority products, and is clinically oriented, focusing on senior reviewers from various review departments to form a team for collective review, with comprehensive review opinions put forward by clinical, engineering and other professional teams. During the review process, reviewers are sent to participate in the verification of the registration quality management system by way of on-site review, so as to objectively and comprehensively understand the innovative and prioritized products and put forward more scientific and reasonable review opinions. In addition, it also combines the supervision mechanism in project management and quality control to realize the effective shortening of product review time compared with the statutory review time limit.
Promoting the Transformation of Innovative Achievements Oriented by Clinical Needs
Clinical evaluation is an important regulatory link in the listing process of innovative medical devices. In recent years, the Center has carried out a series of work in the field of clinical evaluation of medical devices, gradually rationalized the review concept, requirements and framework of clinical evaluation of medical devices, enriched and broadened the sources of clinical data, solved many key issues such as how to carry out clinical trials, and generated new methods and tools for clinical evaluation, and basically formed a scientific clinical evaluation idea. In the review of specific products, the path of clinical evaluation of various products has basically reached a consensus in the regulatory agencies and the industry, and the proportion of clinical trials in product registration and licensing change projects is at a reasonable level.
Constructing a standardized system for technical review of clinical evaluation In recent years, the Center has formulated international coordination documents for clinical evaluation and equivalently transformed them into China’s normative documents, and formulated 8 general guiding principles and 22 recommended paths for clinical evaluation, which comprehensively cover the key issues in the field of clinical evaluation. Meanwhile, a three-tier technical review standardization system has been established with the framework of “general guiding principles for clinical evaluation – guiding principles for clinical evaluation of various types of products – key points for technical review of clinical evaluation of various types of products”. At present, on the basis of the general guiding principles, more than 70 guiding principles for clinical evaluation of various types of products and more than 400 key points for technical review of clinical evaluation have been formulated, basically realizing the comprehensive coverage of the products that need to be clinically evaluated under the three-tier catalog of the Classification Catalogue of Medical Devices, and achieving the clinical evaluation of medical devices with a clear scope of products, a clear path of evaluation and specific evaluation requirements, which provides basic guidelines for the conduct of clinical trials of innovative medical devices. It provides a basic guideline for innovative medical devices to carry out clinical trials.
Enhancing the accessibility of innovative products Enhancing the accessibility of innovative products for clinical use is a key link to meet the treatment needs of patients with serious life-threatening diseases. The Center has continued to pay attention to important issues in this area and has proposed relevant implementation initiatives. For example, the Center has conducted research on conditional approval of medical devices, comprehensively assessed the risks and benefits of the products, and refined the requirements for conditional approval, encouraging the conditional approval of medical devices that are used for treating serious life-threatening diseases and for which there is no effective treatment available as soon as possible; it has also conducted research on the expansion of the use of medical devices in clinical practice, clarified the requirements for expanding the clinical trials, and encouraged the clinical use of medical devices that are used for the treatment of serious life-threatening diseases for which there is no effective treatment. To encourage the clinical use of medical devices for treating serious life-threatening diseases for which there is no effective means of treatment, and to meet the urgent needs of specific patients for clinical treatment to the maximum extent possible while guaranteeing the safety of public use of medical devices; to steadily push forward the pilot work of applying real-world data in Boao Lecheng, innovate the clinical evaluation methods, and actively explore the path of using real-world data for product registration. In response to the above initiatives, it has successively formulated the Guiding Principles for Conditional Approval of Medical Devices for Listing, the Technical Guiding Principles for Clinical Evaluation of Real-World Data for Medical Devices (for Trial Implementation), and participated in the formulation of the Medical Devices
Insist on concentrating efforts
Focus on solving the “neck” problem
General Secretary Xi Jinping attaches great importance to key core technologies. He emphasized that we should focus on key core technology research, accelerate the solution of a number of drugs, medical devices, medical equipment, vaccines and other areas of the “neck” problem; to speed up to make up for the short board of China’s high-end medical equipment, accelerate the key core technology research, breakthroughs in these technological equipment bottlenecks, and realize the independent and controllable high-end medical equipment; to strengthen the basic research and scientific and technological innovation capacity building, and put the lifeblood of the development of the biomedical industry firmly in our own hands. Basic research and scientific and technological innovation capacity building, the lifeblood of the development of the biomedical industry firmly in our own hands.
In order to solve the “neck” problem in the field of medical devices, the technical review of medical devices has identified three key points, focusing on the integration of innovative resources, innovation in work mode, breakthroughs in key issues to start research and put forward the corresponding implementation initiatives. In the integration of innovative resources, based on the mobilization of review resources, the joint government, industry, academia, research and use of all parties, in the field of artificial intelligence and biomaterials to form an open and sharing of innovation and cooperation; in the innovation of the work model, research, promote the review of the center of gravity gradually to the product development stage, the implementation of the medical device pre-review; in the breakthroughs of the key issues, the face of the accelerated to make up for China’s high-end medical equipment short board of the urgent situation. In terms of breaking through key issues, in the face of the urgent situation of accelerating to make up the short board of high-end medical equipment in China, in-depth research and support for domestic high-end medical equipment has been carried out, and certain results have been achieved.
Building an Open and Shared Innovation and Cooperation Platform
In order to grasp the strategic initiative of the new round of scientific and technological revolution and focus on key areas to promote the listing of relevant domestic innovative medical devices, the Center has constructed an open and collaborative medical device innovation system in the fields of artificial intelligence and biomaterials on the basis of analyzing and judging the development situation of China’s medical device field, striving to set up an innovation and cooperation platform for scientific supervision of medical devices, scientific and technological innovation, and product transformation to create a platform for scientific and technological innovation, achievement transformation, government supervision, and product transformation. It strives to build an innovative cooperation platform to serve the scientific supervision of medical devices, scientific and technological innovation and product transformation, and to create a good interactive situation of scientific and technological innovation, achievement transformation, government supervision and industry self-regulation.
Since its establishment and operation in July 2019, the Artificial Intelligence Medical Device Innovation Cooperation Platform has successfully constructed China’s Artificial Intelligence medical device technical requirements, testing methods and other related standard systems, and key guidelines such as “Key Points for Review of Deep Learning-Assisted Decision Making Software for Medical Devices”, “Key Points for Review of Pneumonia CT Imaging Assisted Diagnostic and Evaluation Software (Trial)”, and “Guidelines for the Registration Review of Artificial Intelligence Medical Devices” have been formulated and released successively. Principles have been formulated and released one after another, providing the necessary basic guarantee for the development of AI medical device industry. In addition, the platform has also successfully constructed original databases of tests covering many disease areas such as fundus ultrasound for diabetic retinopathy, CT for pneumonia, thyroid ultrasound, etc. Databases such as cervical cytopathic images and multimodal images for pathological myopia are under construction, providing a way for the collection, management, and use of data for AI products to be pooled and shared.
Since its establishment in April 2021, the Biomaterials Innovation Cooperation Platform has participated in the formulation of guiding principles, review points and technical guidelines covering a variety of fields such as in vitro diagnostic reagents and devices, additive manufacturing, ECMO devices and medical cosmetic materials, which has promoted the transformation and application of scientific and technological achievements in the field of biomaterials and key technologies in the field of medical devices. With the support of the platform, breakthrough progress has been made in the localization of import-dependent raw materials such as polyether ether ketone materials (PEEK) for implants; China continues to lead the international arena in the field of advantageous biomedical materials, such as sodium hyaluronate …… leading class of innovative products continues to increase.
Explore the establishment of pre-review work mechanism
On the basis of summarizing and analyzing the effectiveness of the reform of the medical device review and approval system, the Center for Instrumental Review benchmarked the international advanced review model, and gradually formed an innovative review work ideas, and actively explored part of the review resources to the product development end of the forward movement of the work model. In the previous period, the deployment of arrangements for medical device technical review and inspection of the Yangtze River Delta sub-center and the Bay Area District Center dedicated to guide the jurisdiction of the innovative priority product research and development, in-depth research and screening of relevant domestic high-end, self-developed products to carry out early intervention in the product development pilot, but also synchronized with the study of the review of the center of gravity of the forward shift of the implementation of the specific process, the pilot product assessment methods, dedicated docking project management methods and other details. 2022 In 2022, the government will formally launch the review of medical devices, issue the “Code of Practice for the Review of Key Projects and Key Products for the Technical Review of Medical Devices (for Trial Implementation)”, screen out key projects and medical devices with key core technologies and significant clinical application value, and promote the review of the review of early intervention in the innovative research and development of products by means of early intervention, one enterprise, one policy, whole process guidance, and research and review linkage.
Support the research and development of domestic high-end medical equipment
China’s high-end medical equipment exists in part of the key process constraints, the whole machine manufacturing level is relatively low and other issues. In order to solve the above problems, the Center focuses on the national strategic needs of active thinking, active planning, mastering the industry and the forefront of scientific and technological development, and constantly accumulating the key processes and core technology reserves, supporting the key core technology research and development, accelerating the realization of the process of localization of high-end medical equipment, and accelerating to make up for the short board of high-end medical equipment. We will conduct in-depth research on the current situation of the “choke point” of medical equipment raw materials (components), increase support for high-end medical equipment with independently developed core components such as ECMO, liquid-free helium magnetic resonance, etc., and carry out various forms of research and proactive communication. 2022, the first domestically developed proton therapy system, the first implantable medical equipment with magnetic-liquid levitation technology, and the first implantable medical equipment with magnetic-liquid levitation technology will be developed in the domestic market. implantable left ventricular assist system using magnetic liquid suspension technology will be approved and marketed, and the carbon ion therapy system will have completed its transformation and upgrading; in 2023, three domestically produced ECMO equipment products will be approved and marketed, and the problem of short boards of high-end medical equipments in China will be solved in a sustained and effective manner.
Adhering to the People First
All-out efforts to safeguard epidemic prevention and control
In December 2019, a sudden new crown epidemic seriously threatened the lives and health safety of the people. General Secretary Xi Jinping made important instructions for the prevention and control of the epidemic. Under the strong leadership of the party group of the State Drug Administration, the technical review of medical devices, guided by Xi Jinping’s thought of socialism with Chinese characteristics in the new era, conscientiously implemented the requirements of the “four most stringent”, adhered to the principle of putting the life safety and health of the people in the first place, in accordance with the “unified command, early intervention, scientific approval”, and the “four most stringent” requirements, In accordance with the principles of “unified command, early intervention, on-site review and scientific approval” and the requirements of ensuring product safety, effectiveness and controllable quality, we have completed the emergency review work with high quality, which has provided an effective guarantee for the prevention and control of the epidemic.
Issuance of emergency review points
After the outbreak of the epidemic, the State Drug Administration (SDA) initiated the emergency approval procedure for medical devices at the first time, and determined the scope of products to be included in the emergency approval. In order to support manufacturers to develop new coronavirus detection reagents for epidemic prevention and control as soon as possible and successfully registered on the market, it is particularly important to issue timely guidance documents to guide product development and registration. On the basis of collecting relevant literature and soliciting experts’ opinions, the Center for Instrumental Review (CIR) researched and formulated and globally debuted the “Key Points for Technical Review of the Registration of 2019 Novel Coronavirus Nucleic Acid Detection Reagents” and the “Key Points for Technical Review of the Registration of 2019 Novel Coronavirus Antigen/Antibody Detection Reagents”, which are intended to provide guidance to the applicants in preparing the declaration information, ensure the quality of the review, and expedite the approval of new coronavirus testing reagents for use in prevention and control of epidemic. The new coronavirus detection reagents on the market provide the technical basis. During the epidemic, the Guidelines for Review of Registration of New Coronavirus (2019-nCoV) Antigen Detection Reagents, Guidelines for Review of Pneumonia CT Imaging Assisted Diagnosis and Evaluation Software (Trial), Guidelines for Review of Extracorporeal Membrane Lung Oxygenation (ECMO) Devices, and other important guiding documents have been formulated and released in accordance with the situation of the anti-epidemic, which provide effective guidelines for the technical review and the research and development of the enterprise’s products.
Conducting emergency review
Move on orders and take on heavy burdens. After the State Drug Administration launched the emergency approval procedure, the Center for Instrumental Review (CIRC) has been urgently implementing the emergency review work, highlighting the characteristics of science and high efficiency, and strictly controlling the quality of products. Through the scientific construction of product safety and effective evaluation model, we make accurate judgment on the review requirements of various new products, efficiently communicate with the inspection, system assessment and review of tripartite issues, and synergistically promote the emergency review. Specific modus operandi of the Emergency Review Working Group includes intervening in product development in advance, communicating directly with the R&D team, understanding the R&D situation, and guiding the product design and development paths; conducting timely technical assessment of the products to be declared, and guiding the registration applicants to carry out the registration declaration work in the first time; conducting round-the-clock review of the information submitted by the enterprises, and responding to the problems of the enterprises in the verification of the products in a 24-hour period. At the beginning of the epidemic outbreak, the Center for Instrumental Review completed the review of four nucleic acid testing reagents of four enterprises in four days, and at a later stage, in line with the anti-epidemic situation, the Center scientifically and efficiently completed the emergency review of antigen testing reagents, domestic ECMO equipment and other products, which played a positive role in alleviating the shortage of anti-epidemic medical devices. According to statistics, as of the end of 2023, more than 150 new coronavirus detection reagents, and more than 30 related instruments, software and dressings were approved for marketing, including blood purification equipment, ventilators, ECMO equipment and other key support equipment, which effectively met the needs of epidemic prevention and control.
Post time: May-23-2024