China NMPA Announces New Measures to Boost High-End Medical Device Innovation and Regulatory Support

The National Medical Products Administration (NMPA) of China has introduced a series of strategic measures to accelerate the development of new-quality productivity in the high-end medical device sector. 

Key focus areas include medical robotics, advanced imaging systems, AI-powered medical devices, and novel biomaterial-based devices. These initiatives aim to enhance innovation, optimize regulatory procedures, and strengthen post-market supervision.

1. Optimizing the Special Approval Pathway

The NMPA will continue to implement the special review process for first-in-China, internationally leading high-end medical devices with significant clinical value. The review process will be further streamlined, communication between applicants and reviewers enhanced, and technical guidance strengthened throughout R&D and registration stages. Change registrations for innovative devices will follow the same prioritized pathway. The department also plans to support the market entry of high-end devices listed in national development plans and issue tailored guidance for AI and biomaterial-based “mission-led” technologies. Conditional approvals will be further clarified and explored.

2. Refining Classification and Naming Principles

Guidance will be issued for the classification and naming of surgical and rehabilitation robots, establishing expert consensus for device naming. The NMPA will study emerging technologies such as AI foundation models, synthetic biomaterials, and image preprocessing software to better define their regulatory categories. It will also assess management protocols for core components in robotics and high-end imaging systems.

3. Strengthening the Standards System

To reinforce innovation through standardization, China will accelerate the development of national standards in areas like exoskeleton robots and radiopharmaceutical imaging systems. New basic and performance standards will be introduced for AI devices, high-end imaging, and biomaterials. Efforts include establishing new standards organizations focused on medical robots and AI medical devices, and launching standard dataset research for AI evaluation.

4. Clarifying Registration Review Requirements

Review principles for high-end devices such as laparoscopic systems, MRI equipment, dental bone graft materials, and vascular implants will be updated. Technical guidelines will be drafted for multi-disease AI models, and streamlined change registration procedures will be introduced for algorithm optimization where the core algorithm remains unchanged. Performance evaluation using benchmark datasets and platform equivalency for AI software will be explored. The NMPA will also revise review guidelines for device lifespan and investigate electronic instructions for use (eIFUs).

5. Enhancing Communication and Expert Consultation

Regulatory services will be strengthened across testing, clinical evaluation, and submission guidance. The review focus will shift earlier into the R&D stage for high-end devices. Expert pools will be expanded in specialties such as active devices, materials science, and clinical medicine. A long-term mechanism will be established to support regulatory intelligence and pre-registration system audits, helping enterprises identify and rectify system gaps early.

6. Refining Post-Market Supervision

Innovative devices, especially first-in-China technologies, will undergo joint regulatory consultations to assess innovation points and potential risks. Guidelines for quality system inspections will be introduced for advanced products like carbon ion/proton therapy systems, animal-derived heart valves, 3D-printed implants, and surgical robots. National and provincial inspector training will be strengthened to build a high-performing regulatory inspection team.

7. Enhancing Quality and Safety Monitoring

Regulations on the service life management of active high-end devices will be studied. Hospitals will be required to regularly inspect and maintain devices like surgical robots and imaging systems. Manufacturers will be encouraged to conduct real-world evidence (RWE) studies and report adverse events more accurately. China will continue participating in global surveillance initiatives, such as GHWP projects, and guide manufacturers in using new signal detection tools for post-market data utilization.

8. Following Industry Trends

The NMPA will publish a regularly updated list of approved high-end devices and establish a dedicated research group to issue annual industry development and regulatory insight reports. It will maintain an open communication channel with associations and academic institutions to monitor industry trends, address challenges, and propose regulatory recommendations.

9. Advancing Regulatory Science

Collaborative innovation platforms for AI, biomaterials, and high-end medical equipment will be leveraged to accelerate new tools, standards, and methods. Research will focus on the safety and performance evaluation of brain–computer interface (BCI) devices, synthetic biomaterials, and real-world data applications. The aim is to establish a science-based regulatory framework aligned with emerging technologies.

10. Promoting Global Regulatory Alignment

China will actively participate in international standard development, strengthen domestic regulatory training, and engage in forums like IMDRF and GHWP. Support will be extended to help Chinese high-end device companies expand globally, with improvements to the export certificate system and broader international promotion of China's regulatory innovations and medical device achievements.