Medical robots, high-end medical imaging equipment, AI-powered medical devices, and novel biomaterial-based medical devices (hereinafter referred to as "high-end medical devices") are key areas for fostering new quality productivity in the medical device industry. To thoroughly implement the principles of the Third Plenary Session of the 20th CPC Central Committee and the requirements of the Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Regulation of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry (GBF [2024] No. 53), and to improve the review and approval mechanisms, strengthen full life-cycle regulation, 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 healthcare field, better meet public health needs, and enhance China's international competitiveness in high-end medical devices, the National Medical Products Administration hereby proposes the following supporting measures:

　　I. Optimize Special Approval Procedures

　　For domestically pioneered, internationally leading high-end medical devices that meet relevant requirements and demonstrate significant clinical application value, continue to implement the special review procedures for innovative medical devices. Further optimize the review procedures for innovative medical devices, enhance communication between applicants and review experts, and strengthen technical guidance for the R&D and registration of innovative medical devices. For the change registration of high-end innovative medical devices, conduct reviews in accordance with the special review procedures for innovative medical devices. Support the accelerated market entry of high-end medical devices covered under national-level high-quality development action plans and other industrial policies. Strengthen the registration guidance for AI-powered and biomaterial-based products in the framework of the "open competition mechanism to select the best candidates", and collaborate with relevant departments to issue supporting policies for medical device products based on the brain-computer interface technology. For high-end medical devices granted conditional approval in accordance with the law, explore specific requirements for such conditional approvals.

　　II. Refine Classification and Naming Principles

　　Enhance guidance on product classification and naming to support registration applications for high-end medical devices. Formulate classification guidelines for medical robots, such as surgical robots and rehabilitation robots, and establish expert consensus on medical robot naming. Conduct research on the management attributes and categories of products with new functions, technologies, and modalities, including large medical models, AI-powered medical devices, synthetic biomaterial-based tissue engineering products, medical imaging preprocessing, process optimization software, etc. Dynamically adjust the management categories of these products in a timely manner based on technological maturity. Study and refine the management requirements for core components of medical robots and high-end medical imaging equipment.

　　III. Continuously Improve the Standards System

　　Strengthen the role of standards in guiding innovation and further improve the standards system for high-end medical devices. Accelerate the release of relevant standards for medical exoskeleton robots, radionuclide imaging equipment, etc. Expedite the formulation and revision of fundamental, general, and methodological standards in areas such as medical robots, AI-powered medical devices, and high-end medical imaging equipment. Actively prepare for the establishment of technical standardization organizations for medical robots and AI-powered medical devices. Strengthen standardization research on novel biomaterials, including medical materials for additive manufacturing, flexible electrodes for brain-computer interfaces, genetically engineered synthetic biomaterials, etc. Conduct research on standard datasets for AI-powered medical devices. Based on industry development and regulatory needs, promote the rapid initiation of urgently needed standards for high-end medical devices through expedited procedures.

　　IV. Further Clarify Registration Review Requirements

　　Scientifically formulate review requirements for high-end medical devices and improve the registration review system for high-end medical devices. Accelerate the formulation and revision of technical review guidelines for related products such as laparoscopic surgical systems, medical magnetic resonance imaging systems, dental bone graft materials for implantation, nickel-titanium alloy endovascular implantable/interventional devices, etc. Research and formulate relevant technical guidelines or review points for multi-disease and large-model AI fields. Simplify the change registration requirements for AI-powered medical devices where the core algorithm remains unchanged, but algorithm performance is optimized. Explore and improve the requirements for performance evaluation of AI-powered medical devices using evaluation databases. For the same AI software function registered for different platforms, streamline review requirements if the equivalence of the platforms can be demonstrated. Investigate the application of AI, biochips, and other technologies in the performance and safety evaluation of biomaterial-based medical devices. Revise the technical review guidelines for the service life registration of high-end active medical devices. Explore pathways and requirements for the electronic instructions for use of high-end medical devices.

　　V. Improve Communication, Guidance, and Expert Consultation Mechanisms

　　Strengthen service guidance and communication regarding the testing, clinical evaluation, and registration application dossiers for high-end medical devices. Shift the focus of the review earlier into the R&D phase of high-end medical devices, and enhance early-stage review efforts. Further improve the expert pool for the review of high-end medical devices by expanding the number of experts in related active devices, medical materials, and clinical fields, and broadening the professional and research areas covered by the expert pool. Establish a long-term mechanism for intellectual support from experts to provide suggestions and measures for cutting-edge high-end medical devices. Explore mechanisms to advance the registration system inspections of innovative high-end medical devices earlier, advance inspection checkpoints, and adopt a phased inspection model to timely help enterprises identify and address system deficiencies.

　　VI. Refine Post-Market Surveillance Requirements

　　Select representative innovative medical devices, such as those that are domestically pioneered, to conduct regulatory consultations. Guide provinces with a high concentration of innovative medical devices to carry out local regulatory consultations, analyze innovation points and risk points, and study targeted regulatory measures. Accelerate the formulation of quality management system inspection points for innovative products such as carbon ion/proton therapy systems, animal-derived artificial heart valves, metal additive manufactured bone implants, and PEEK suture anchors, as well as high-end products such as medical surgical robots, AI-powered medical devices, and recombinant collagen. Strengthen the selection and training of national-level inspectors, cultivating a cohort of national-level inspectors for high-end medical devices. Conduct quality management system verification for provincial inspection agencies, enhance their capacity building, and improve inspection quality and efficiency.

　　VII. Strengthen Post-Market Quality and Safety Monitoring

　　Research the management requirements for the service life of high-end active medical devices in use. Urge medical device using entities to conduct regular inspections and maintenance of medical devices such as surgical robots, rehabilitation robots, high-end medical imaging equipment, etc., to ensure their quality in clinical use. Support medical device registrants in conducting post-market evidence-based studies. Refine the types of adverse events related to medical devices such as high-end medical imaging equipment, AI-powered medical devices, etc., draft corresponding reporting scope specifications, and improve adverse event reporting quality. Continue to promote new projects for active monitoring proposed by the Global Harmonization Working Party (GHWP). Starting with high-risk cardiovascular implantable medical devices, explore the fundamental framework for post-market active monitoring of medical devices and develop methods for related database construction. Guide registrants to utilize new tools and methods for medical device vigilance to detect and utilize adverse event monitoring data signals. Guide registrants to actively conduct post-market evaluations to continuously enhance the safety and reliability of their products. Guide local authorities in strengthening the construction of inspection and monitoring teams for high-end medical devices, to improve their inspection and monitoring capabilities.

　　VIII. Closely Follow Industrial Development

　　Regularly publish a list of approved high-end medical devices to the public. Establish a high-end medical device industry development research working group to annually compile reports on scientific regulation and industrial development of high-end medical devices, research and release information on industry status and trends, and propose recommendations for promoting high-quality industrial development. Leverage the expert resources of industry associations and academic societies, and establish a regular communication mechanism. Promptly collect, organize, summarize, and analyze the development trends of high-end medical devices, identify problems encountered during development, and propose regulatory recommendations.

　　IX. Advance Regulatory Science Research

　　Fully leverage the collaborative innovation platforms for AI-powered medical devices, biomaterials, and high-end medical equipment, and actively track cutting-edge advancements and scientific developments in high-end medical devices, to accelerate the development of new tools, standards, and methods. Advance key projects for the construction of the regulatory science system, such as research on the performance and safety evaluation of innovative biomaterial-based medical devices, research on systematic evaluation methods for the safety and effectiveness of medical devices based on the brain-computer interface technology, etc. Make early arrangements for regulatory science projects for high-end medical devices, and strengthen technical regulatory preparedness. Continue to conduct real-world studies on high-end medical devices, and promote the use of real-world evidence in regulatory decision-making.

　　X. Promote Global Regulatory Harmonization

　　Actively participate in international standard setting, accelerate the adoption and application of international standards, and strengthen training on domestic regulatory laws and standards. Actively engage in international regulatory organizations such as the International Medical Device Regulators Forum (IMDRF) and GHWP, as well as international exchange and cooperation with regulatory authorities in countries and regions participating in the Belt and Road Initiative. Support the global expansion of high-end medical device manufacturers by refining policies related to medical device export sales certificates, and broadening the scope of their issuance. Leverage international exchange platforms to promptly identify emerging trends of international innovative medical device products, and actively showcase China's regulatory models and innovative achievements in medical devices.

　　It is hereby announced.

　　National Medical Products Administration

　　June 27, 2025

　　(Excerpt from: National Medical Products Administration website 2025-07-03)