Medical devices such as surgical robots, high-end medical imaging systems, AI medical devices, and innovative biomaterials (hereinafter collectively referred to as "high-end medical devices") play a pivotal role in shaping new-type productive forces within the medical device sector. In order to thoroughly implement the spirit of the 20th CPC Central Committee's Third Plenary Session and align with the requirements of the General Office of the State Council's "Opinions on Deepening Reform of Drug and Medical Device Regulatory Systems to Promote High-Quality Development of the Pharmaceutical and Medical Device Industry" (Guo Ban Fa [2024] No. 53), the National Medical Products Administration (NMPA) herein proposes the following measures: to improve the review and approval mechanisms, strengthen whole-lifecycle regulation, fully support major innovations in high-end medical devices, facilitate the application of new technologies, materials, techniques and methods in healthcare, better meet the people's health needs, and enhance the international competitiveness of China's high-end medical device sector.
1. Optimize Special Approval Procedures
Continue implementing innovative special review for domestically pioneering, internationally leading high-end medical devices with significant clinical value; further optimize the innovation review process; enhance communication between applicants and review experts; and strengthen technical guidance for innovation and registration. For registration changes of high-end innovative medical devices, review them under the special innovation review process. Support accelerated market entry of high-end medical devices included in national high-quality development plans. Enhance registration guidance for "targeted breakthrough" AI and biomaterials products; coordinate with relevant departments to introduce support policies for brain–computer interface-based devices. For high-end medical devices conditionally approved by law, explore detailed requirements for conditional approval.
2. Improve Classification and Nomenclature Principles
Strengthen product classification and nomenclature guidance to support registration applications of high-end medical devices. Develop classification guidance for surgical robots, rehabilitation robots, and other medical robots, reaching expert consensus on nomenclature. Conduct research on the regulation and categorization of novel-function, novel-technology, novel-modality products such as medical large models, AI medical devices, synthetic biomaterials, imaging pre-processing, and workflow-optimizing software. Dynamically adjust management categories according to technological maturity. Refine management requirements for core components of medical robots and high-end medical imaging systems.
3. Continuously Improve the Standards System
Reinforce standardization to guide innovation and improve the standard system for high-end medical devices. Accelerate the issuance of standards for exoskeleton medical robots and radionuclide imaging equipment. Expedite revision and development of foundational, general, and method standards for medical robots, AI medical devices, and high-end imaging equipment; actively establish standardization technical committees in those fields. Strengthen standardization research on innovative biomaterials such as additive manufacturing materials, BCI flexible electrodes, and genetically engineered biomaterials. Advance the research of standard datasets for AI medical devices. Use fast-track procedures to launch urgently needed standards for high-end medical devices based on industry demand and regulatory needs.
4. Clarify Registration and Review Requirements
Formulate scientific review requirements and improve review systems for high-end medical devices. Accelerate the drafting and revision of technical review guidance for products such as laparoscopic surgical systems, MRI systems, implantable oral bone graft materials, and nitinol vascular implants. Develop technical guidance or review points for multi-disease-type, large-model AI fields; simplify registration requirements for AI medical devices whose core algorithm remains the same but whose performance is optimized. Explore using performance evaluation databases for AI device performance assessment; simplify review when the same AI software functions are registered on different platforms and platform equivalence is demonstrated. Research the application of AI and biochips in evaluating performance and safety of biomaterial medical devices. Revise registration guidance on service life for high-end active medical devices. Explore pathways and requirements for using electronic instructions for high-end medical devices.
5. Strengthen Communication and Expert Consultation Mechanisms
Enhance service guidance and communication on high-end medical device testing, clinical evaluation, and registration materials; shift review emphasis earlier into product development (pre-market review). Further improve the expert review panel for high-end devices by expanding expert numbers in active devices, medical materials, clinical specialties, and diversifying their expertise. Establish a long-term expert advisory mechanism to provide support and measures for frontier high-end medical device technologies. Explore pre-market inspection verification mechanisms for high-end innovative device registration systems; move inspection checkpoints upstream and adopt phased inspection models to help enterprises promptly identify and improve system deficiencies.
6. Refine Post-Market Regulatory Requirements
Convene regulatory consultations for representative domestically pioneering innovative devices and coordinate localized regulatory consultations in key provinces to analyze innovation and risk points and study targeted regulatory measures. Speed up drafting checklist for quality management system inspections for innovative products such as carbon ion/proton therapy systems, animal-derived artificial heart valves, metal additive manufacturing bone implants, PEEK screw-anchoring nails, surgical robots, AI devices, and recombinant collagen. Strengthen selection and training of national-level inspectors for high-end medical devices; conduct validation of provincial inspection agencies' QMS, strengthen provincial inspection capabilities, and improve inspection quality and efficiency.
7. Enhance Post-Market Quality and Safety Monitoring
Research requirements for service life management of high-end active medical devices in use. Urge medical institutions to carry out regular maintenance of surgical robots, rehabilitation robots and advanced medical imaging equipment to ensure clinical quality. Support marketing authorization holders in conducting post-market evidence-based research. Refine adverse event classification for high-end imaging equipment and AI devices, and formulate specifications for reporting scope to improve the quality of adverse event reports. Continuously promote the implementation of proactive monitoring projects under the GHWP framework, using high-risk cardiovascular implantable devices as entry points, explore post-market monitoring frameworks and database construction methods, and guide marketing authorization holders to adopt new vigilance tools and methods for signal detection and utilization. Encourage holders to conduct proactive post-market evaluations to continuously enhance product safety and reliability. Guide local authorities to strengthen the inspection and monitoring capabilities for high-end medical devices.
8. Closely Monitor Industry Development
Regularly publish to the public lists of approved high-end medical devices. Establish a working group on the development of the high-end medical device industry, compile annual reports on scientific regulation and industry development, research and disseminate the state and trends of the industry, and propose measures to promote high-quality development. Make full use of the expertise of industry associations to establish regular communication mechanisms, collect and analyze industry development trends and regulatory issues, and provide regulatory recommendations.
9. Advance Regulatory Science Research
Rely on innovation cooperation platforms in the fields of AI medical devices, biomaterials and high-end medical equipment to track research and development and technological progress in high-end medical devices, and accelerate the development of new tools, standards and methods. Promote major regulatory science research projects such as the evaluation of the performance and safety of innovative biomaterials and the systematic evaluation of brain–computer interface devices. Lay the groundwork for regulatory science research projects on high-end medical devices and strengthen preparedness in regulatory science capabilities. Continue to conduct real-world studies of high-end medical devices and promote the application of real-world evidence in regulatory decision-making.
10. Promote Global Regulatory Coordination
Actively participate in the development of international standards, accelerate the adoption of international standards, and strengthen training on domestic regulatory laws and standards. Actively engage in the work of the IMDRF, GHWP and cooperation with regulatory authorities of countries and regions along the Belt and Road. Support high-end medical device enterprises in "going global", improve policies on export certification, and expand the scope of export certificate issuance. Through international exchange platforms, promptly identify innovation pathways worldwide, and actively promote China's regulatory models and achievements in medical device innovation.
How Qualtech Can Support Your Market Entry in China
With these new measures in place, China is creating a more favorable environment for innovative medical devices — but navigating the regulatory process remains complex. From eligibility assessment to submission preparation and lifecycle compliance, having the right local expertise is crucial.
Qualtech's dedicated team in China can support you with:
- Regulatory strategy and pathway assessment
- Product registration and submission to NMPA
- Acting as your local Authorized Representative (AR) in China
- Post-market surveillance and compliance management
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