National Medical Products Administration openly solicits opinions on "Measures to optimize the full life cycle supervision to support the innovation and development of high-end medical devices (draft for soliciting opinions)"

On March 31st, the National Medical Products Administration Comprehensive Department publicly solicited opinions on the "Measures for Optimizing the Supervision of the Entire Life Cycle to Support the Innovation and Development of High-end Medical Devices (Draft for Soliciting Opinions)". It mentioned accelerating the revision work of basic, general standards and method standards in the fields of medical Siasun Robot&Automation, artificial intelligence medical devices, high-end medical imaging equipment, etc., actively establishing the Medical Siasun Robot&Automation and Artificial Intelligence Medical Device Standardization Technical Committee. Strengthen the standardization research of new biomaterials such as additive manufacturing medical materials, brain-machine interface flexible electrodes, and genetically engineered synthetic biomaterials. The original text is as follows: National Medical Products Administration's Measures to Optimize the Supervision of the Entire Life Cycle to Support the Innovation and Development of High-end Medical Devices (Draft for Soliciting Opinions) Medical Siasun Robot&Automation, high-end medical imaging equipment, artificial intelligence medical devices, and new biomaterial medical devices (hereinafter referred to as high-end medical devices) are key areas shaping the new quality productivity of medical devices. In order to thoroughly implement the spirit of the 3rd Plenary Session of the 20th Central Committee of the Communist Party of China and implement the Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Supervision to Promote the High-quality Development of the Pharmaceutical Industry (State Council Office [2024] No. 53), improve the evaluation and approval mechanism, strengthen the supervision of the entire life cycle, fully support major innovations in high-end medical devices, promote the application of more new technologies, new materials, new processes, and new methods in the field of medical health, better meet the health needs of the people, the National Medical Products Administration proposes the following support measures. 1. Optimize special approval procedures For high-end medical devices that are domestically pioneering, internationally leading, and have significant clinical application value and meet the requirements, continue to implement special innovative reviews and further clarify the innovative review standards and optimize the expert review mechanism. For changes in registration of high-end Innovative Medical Management devices, review them in accordance with the special innovative review procedure. Support high-end medical devices involved in national high-quality development action plans and other industry policies to be listed faster. Strengthen the registration guidance for artificial intelligence, biomaterials, "flagship" products, and coordinate with relevant departments to introduce support policies for medical devices based on brain-machine interface technology. For high-end medical devices that are conditionally approved in accordance with the law, explore the specific requirements of conditional approval. 2. Improve classification and naming rules Strengthen guidance on product classification and naming to support the registration declaration of high-end medical devices. Formulate classification guidance principles for medical Siasun Robot&Automation such as surgical Siasun Robot&Automation, rehabilitation Siasun Robot&Automation, and establish a consensus of experts on the naming of medical Siasun Robot&Automation. Conduct management attribute and category research on new functional, technical, and modal products such as medical large-scale models, artificial intelligence medical devices, synthetic biomaterial tissue engineering products, and medical imaging reconstruction software, and adjust product management categories in a timely manner based on the maturity of technological development. Elaborate on the core component management requirements of medical Siasun Robot&Automation and high-end medical imaging equipment. 3. Continuously improve the standard system Strengthen standard-led innovation and further improve the standard system for high-end medical devices. Accelerate the release of standards for medical exoskeleton Siasun Robot&Automation, radiopharmaceutical imaging equipment, and other related standards. Accelerate the revision work of basic, general standards and method standards in the fields of medical Siasun Robot&Automation, artificial intelligence medical devices, high-end medical imaging equipment, and actively establish the Medical Siasun Robot&Automation and Artificial Intelligence Medical Devices Standardization Technical Committee. Strengthen the standardization research of new biomaterials such as additive manufacturing medical materials, brain-machine interface flexible electrodes, and genetically engineered synthetic biomaterials. Carry out research on the digital standard sample dataset of artificial intelligence medical devices. According to industrial development and regulatory needs, promote the urgent need for standardization of high-end medical devices through fast track procedures. 4. Further clarify the registration review requirements Scientifically formulate the evaluation requirements for high-end medical devices and improve the registration review system for high-end medical devices. Accelerate the revision of technical review guidance principles for products such as laparoscopic surgical systems, medical magnetic resonance imaging systems, dental bone filling materials for implantation, and nitinol vascular interventional devices. Study and formulate technical guidance principles or evaluation points for multi-disease, large-scale artificial intelligence fields. Simplify the registration requirements for changes in performance optimization of core algorithms of artificial intelligence medical devices. Explore and improve the performance evaluation requirements of artificial intelligence medical devices using evaluation databases. For the same artificial intelligence software function registered on different platforms, if the equivalence of platforms can be proven, simplify the evaluation requirements. Study the application of technologies such as artificial intelligence and biochips in the performance and safety evaluation of biomaterial medical devices. Revise the technical review guidance principles for high-end active medical devices using lifetime registration. Explore the path and requirements for using electronic instructions for high-end medical devices after listing. 5. Improve communication guidance mechanisms and expert consultation mechanisms Strengthen service guidance and communication exchanges in aspects such as product testing, clinical evaluation, and registration declaration for high-end medical devices. Promote the focus of evaluation to move towards the research and development stage of high-end medical devices and strengthen pre-evaluation work. Further enrich the expert database for high-end medical device evaluation, increase the number of experts in research, engineering, and clinical fields related to high-end medical devices, and establish a high-end medical device expert consultation committee. Establish a long-term mechanism of expert intellectual support to propose support suggestions and measures for high-end medical devices at the forefront of technological development. Explore the pre-verification mechanism of the registration system for high-end Innovative Medical Management devices, promote the forward movement of inspection checkpoints and the staged inspection model, and promptly help companies identify and improve system deficiencies. 6. Elaborate on post-market supervision requirements Select representative domestic innovations, such as InnoThe regulatory consultation for the Innovative Medical Management equipment is carried out to guide the local regulatory consultation in the provinces where the equipment is centralized. It involves analyzing innovative points and risks, and researching targeted regulatory measures. Accelerate the development of innovative products such as carbon ion/proton therapy systems, animal-derived artificial heart valves, metal additive manufactured bone implants, polyetheretherketone sutures with anchor nails, as well as quality management system inspection points for medical surgical Siasun Robot & Automation, artificial intelligence medical equipment, recombinant collagen protein, and other high-end products. Strengthen the selection and training of national inspectors, cultivate a group of high-end medical equipment national inspectors; carry out quality management system verification for provincial inspection agencies, strengthen the capacity building of provincial inspection agencies, and improve inspection quality and efficiency.Seven, strengthen post-listing quality monitoring Research on the requirements for the management of high-end active medical devices during their use. Urge medical device users to regularly inspect and maintain surgical Siasun Robot & Automation, rehabilitation Siasun Robot & Automation, and high-end medical imaging equipment to ensure clinical quality. Support medical device registrants in conducting post-market evidence-based research. Refine the types of adverse events for high-end medical imaging equipment and artificial intelligence medical devices, write corresponding report scope norms, and improve the quality of adverse event reporting. Continuously promote the Global Harmonization Task Force (GHWP) to actively monitor new projects, starting with high-risk medical devices in the cardiovascular implant category, explore the development of a promotable basic framework for post-market active monitoring of medical devices, guide registrants in using new tools and methods for medical device signal mining and utilization for adverse event monitoring data. Guide companies to actively conduct post-market evaluations to continuously improve the safety and reliability of products. Guide localities to strengthen the inspection and alert team construction of Innovative Medical Management equipment, and enhance the inspection and monitoring capabilities of Innovative Medical Management equipment. Eight, closely follow industrial development Regularly publicize the list of approved high-end medical device products. Establish a high-end medical device industry development research working group, organize the annual preparation of reports on scientific regulation and industrial development of high-end medical devices, research and release industry status and trend information, propose measures and suggestions for promoting high-quality industrial development. Give full play to the advantages of expert resources from industry associations, societies, and other units, establish regular communication mechanisms, timely collect, collate, summarize, and analyze the development trends of high-end medical devices, analyze problems encountered in development, and propose regulatory suggestions. Nine, promote regulatory scientific research Give full play to the role of the artificial intelligence medical device innovation platform, the biomaterial innovation cooperation platform, and the high-end medical equipment innovation platform, actively track the research progress and scientific and technological development trends of cutting-edge high-end medical devices, accelerate the development of new tools, standards, and methods. Promote key projects in the construction of regulatory scientific systems, such as the evaluation research on the performance and safety of innovative biomaterial medical devices, and the research on the safety and effectiveness assessment system based on brain-machine interface technology for medical devices, in advance layout regulatory scientific research projects for high-end medical devices, strengthen regulatory technical reserves. Continue to conduct real-world research on high-end medical devices, promote the use of real-world evidence for regulatory decision-making. Ten, promote global regulatory coordination Actively participate in the formulation of international standards, accelerate the application of international standards transformation, and strengthen the training of domestic regulatory laws and standards. Actively participate in international regulatory organizations such as the International Medical Device Regulators Forum (IMDRF), GHWP, as well as international exchanges and cooperation with regulatory authorities in countries and regions along the "Belt and Road." Support high-end medical device companies in their "going global" development, improve policies related to medical device export sales certification, and expand the scope of export sales certification issuance. Rely on international exchange platforms to timely capture new opportunities for international medical device innovation products, and actively promote China's medical device regulatory model and innovation achievements. This article is excerpted from the National Medical Products Administration, GMTEight editor: Chen Wenfang.