The General Office of the National Medical Products Administration has issued the "Measures for Optimizing the Full Life Cycle Regulation to Support the Development of High-End Medical Devices (Draft for Soliciting Opinions)" for public consultation. The draft proposes to strengthen standard leadership innovation and further improve the standard system for high-end medical devices. It accelerates the release of related standards such as medical exoskeleton robots and radionuclide imaging equipment. It also expedites the formulation and revision of foundational, universal standards and method standards in areas like medical robots, artificial intelligence medical devices, and high-end medical imaging equipment, actively establishing technical committees for medical robots and artificial intelligence medical devices. It strengthens the standardization research on new biomaterials such as additively manufactured medical materials, flexible electrodes for brain-computer interfaces, and gene-engineered synthetic biomaterials. It conducts studies on digital standard sample datasets for artificial intelligence medical devices. Based on the development of the industry and regulatory needs, it promotes the initiation of urgently needed standards for high-end medical devices through fast-track procedures.

Measures by the National Medical Products Administration to optimize the whole lifecycle regulation and support the innovative development of high-end medical devices.

(Draft for Comments)

Medical robots, high-end medical imaging equipment, AI-powered medical devices, and new biomaterial medical devices (hereinafter referred to as high-end medical devices) are key areas in shaping the new quality productive forces of the medical device industry. To thoroughly implement the spirit of the Third Plenary Session of the 20th CPC Central Committee, fulfill the requirements of the *State Council's Notice on Comprehensively Deepening Reforms in Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry* (State Council Document [2024] No. 53), improve the review and approval mechanisms, strengthen full lifecycle supervision, fully support major innovations in high-end medical devices, and promote the application of more new technologies, materials, processes, and methods in the healthcare sector to better meet public health needs, the National Medical Products Administration has proposed the following supportive measures.

Optimize Special Approval Procedures

High-end medical devices that meet the criteria of being domestically pioneering, internationally leading, and having significant clinical application value will continue to undergo special innovation examination. The standards for such examinations will be further clarified, and the expert review mechanism optimized. For changes in registration for high-end innovative medical devices, reviews will be conducted according to the special innovation examination procedures. Support will be provided for the expedited market entry of high-end medical devices mentioned in national-level high-quality development action plans and other industrial policies. Registration guidance will be strengthened for AI and biomaterial products selected through the "call for proposals" system, and cooperation with relevant departments will be enhanced to develop support policies for medical devices based on brain-computer interface technology. For high-end medical devices approved under conditional approval, specific requirements for such approvals will be explored.

II. Improve classification and naming rules

Strengthen guidance on product classification and naming for relevant products to support the registration and application of high-end medical devices. Develop classification guidelines for medical robots such as surgical robots and rehabilitation robots, and form an expert consensus on the naming of medical robots. Conduct research on the management attributes and categories of new functional, technological, and modal products such as medical large models, artificial intelligence medical devices, synthetic biomaterial tissue engineering products, and medical imaging reconstruction software. Dynamically adjust product management categories based on the maturity of technological development. Refine management requirements for core components of medical robots and high-end medical imaging equipment.

3. Continuously improve the standard system

Strengthen innovation through standard leadership and further improve the high-end medical device standard system. Accelerate the release of standards related to medical exoskeleton robots and radionuclide imaging equipment. Expedite the formulation and revision of basic, general, and methodological standards in areas such as medical robots, AI medical devices, and high-end medical imaging equipment, and actively establish standardization technical committees for medical robots and AI medical devices. Enhance standardization research on new biomaterials such as medical materials for additive manufacturing, flexible electrodes for brain-computer interfaces, and genetically engineered synthetic biomaterials. Conduct research on digital standard sample datasets for AI medical devices. Based on industry development and regulatory needs, promote the urgent standardization of high-end medical devices through fast-track procedures.

IV. Further Clarify the Requirements for Registration Review

Scientifically formulate the evaluation requirements for high-end medical devices and improve the registration and 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, oral bone filling materials for implants, and nickel-titanium alloy intravascular implants. Develop technical guidelines or review points for the multi-disease and large-model artificial intelligence fields; simplify the change registration requirements for AI medical device products with unchanged core algorithms but optimized algorithm performance; explore and improve the requirements for performance evaluation of AI medical devices using test databases; for the same AI software function registered on different platforms, if platform equivalence can be proven, simplify the review requirements. Study the application of AI and biochip technologies in the performance and safety evaluation of biomaterial medical devices. Revise the technical review guidelines for the registration of high-end active medical devices' service life. Explore the pathways and requirements for high-end medical devices to use electronic instructions.

Five, improve the communication guidance mechanism and expert consultation mechanism

Strengthen service guidance and communication exchanges for high-end medical device product testing, clinical evaluation, and registration application documentation. Shift the focus of the review process to earlier stages of high-end medical device product development, and enhance preliminary review work. Further enrich the expert database for reviewing high-end medical devices by increasing the number of experts in research, engineering, clinical practices, and other relevant fields, and establish a High-End Medical Device Expert Advisory Committee. Build a long-term mechanism for expert intellectual support to propose suggestions and measures for supporting high-end medical devices at the forefront of technological development. Explore a mechanism to move the pre-inspection work for the registration system of innovative high-end medical devices forward, promoting earlier inspection points and phased inspection models to help companies identify and improve system deficiencies in a timely manner.

Six, refine post-listing regulatory requirements.

Select domestically pioneering and other representative innovative medical devices to carry out regulatory consultations, guide provinces with a concentration of innovative medical devices to conduct local regulatory consultations, analyze innovation points and risk points, and study targeted regulatory measures. Accelerate the formulation of inspection key points for the quality management systems of innovative products such as carbon ion/proton therapy systems, animal-derived artificial heart valves, metal additive manufactured bone implants, polyetheretherketone suture anchors, as well as high-end products like medical surgical robots, artificial intelligence medical devices, and recombinant collagen. Strengthen the selection and training of national-level inspectors, cultivate a group of high-end medical device national-level inspectors; carry out verification of the quality management systems of provincial inspection institutions, enhance the capacity building of provincial inspection institutions, and improve the quality and efficiency of inspections.

Strengthen post-listing quality monitoring.

Research on the management requirements for the service life of high-end active medical devices in use. Urge medical device users to conduct regular inspections and maintenance of surgical robots, rehabilitation robots, and high-end medical imaging equipment to ensure clinical quality. Support medical device registrants in conducting post-market evidence-based studies. Refine the types of adverse events for high-end medical imaging equipment and AI medical devices, and develop corresponding reporting scope standards to improve the quality of adverse event reports. Continue to promote the Global Harmonization Working Party (GHWP) in initiating new active monitoring projects, using high-risk cardiovascular implantable medical devices as a starting point to explore the development of a scalable basic framework for post-market active monitoring of medical devices. Guide registrants to utilize new tools and methods in medical device vigilance for signal detection and utilization of adverse event monitoring data. Encourage companies to proactively conduct post-market evaluations to continuously enhance product safety and reliability. Guide local authorities in strengthening the development of inspection and vigilance teams for innovative medical devices, improving the inspection and monitoring capabilities for such devices.

8. Closely follow up on industrial development

Regularly publish the list of approved high-end medical device products to the public. Establish a research working group for the development of the high-end medical device industry, organize the compilation of an annual report on scientific regulation and industrial development of high-end medical devices, study and release information on industry status and trends, and propose measures to promote high-quality industrial development. Fully leverage the expert resources of industry associations and academic institutions, establish a regular communication mechanism, promptly collect, organize, summarize, and analyze the development trends of high-end medical devices, identify issues encountered in development, and provide regulatory recommendations.

IX. Advancing Regulatory Science Research

Give full play to the roles of the Artificial Intelligence Medical Device Innovation Cooperation Platform, Biomaterials Innovation Cooperation Platform, and High-End Medical Equipment Innovation Cooperation Platform, actively track cutting-edge advancements and scientific developments in high-end medical devices, and accelerate the development of new tools, standards, and methods. Advance key projects in regulatory science systems, such as research on the performance and safety evaluation of innovative biomaterial-based medical devices and systematic evaluation methods for the safety and efficacy of medical devices based on brain-computer interface technology. Proactively plan research projects in regulatory science for high-end medical devices to 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.

1. Tenth, promote global regulatory coordination

Actively participate in the formulation of international standards, accelerate the application of international standard conversions, and strengthen training on domestic regulatory standards. Engage proactively in international regulatory organizations such as the International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Working Party (GHWP), as well as international exchanges and cooperation with drug regulatory agencies in Belt and Road countries and regions. Support high-end medical device companies in expanding overseas, refine policies related to medical device export sales certificates, and broaden the scope of issuance for such certificates. Leverage international exchange platforms to promptly identify new opportunities in innovative international medical device products, and actively promote China’s medical device regulatory model and innovation achievements.