China NMPA Announces Strategy to Advance High-End Medical Device Regulation

With the aim of strengthening its position in the global healthcare market, China is advancing high-end medical device regulation. On July 9, 2025, China's National Medical Products Administration (NMPA) published “Announcement on Optimizing Full Lifecycle Regulation to Support the Innovative Development of High-End Medical Devices” (Announcement No. 63 of 2025).

Scope of the NMPA Announcement

The policy highlights medical robots, advanced imaging systems, AI-driven medical technologies, and novel biomaterial medical devices as priority areas—collectively defined as “high-end medical devices.”

To accelerate innovation in these areas, the NMPA has proposed 10 updates to China’s medical device regulations, broadly aimed at:

Streamlining review and approval processes for high-end medical devices.
Strengthening lifecycle supervision to enhance public health outcomes.
Accelerating the adoption of new technologies, materials and methods to reinforce China’s position in the global high-end medical device market.

For international high-end medical device manufacturers, the proposals signal faster approvals and clearer compliance pathways, supported by closer alignment with international regulatory standards. In turn, these changes are expected to ease Chinese market entry while reducing overall compliance costs.

NMPA’s 10 Measures to Support High-End Medical Device Innovation

The announcement moves beyond broad objectives by setting out a concrete package of proposals designed to reshape medical device regulations. These focus on reforms across product registration, classification, and post-market oversight, aiming to accelerate medical device innovation in China.

The key measures are summarised as follows:

1. Accelerate Market Entry for Innovative High-End Medical Devices

To speed access for breakthrough technologies, the NMPA proposes to:

Optimise the "Special Review Procedure for Innovative Medical Devices" to enhance guidance for products that are first-in-class in China and world-leading.
Apply the innovative review procedure to changes in registration for high-end devices.
Develop support policies for brain-computer interface technology and explore conditional approval pathways.

2. Standardise Classification and Naming Systems

To improve consistency and reduce uncertainty, medical device regulators intend to:

Establish classification standards and naming consensus for medical robots, such as surgical and rehabilitation robots.
Dynamically adjust management categories for emerging products such as AI models and synthetic biomaterials.
Clarify requirements for core components to reduce registration uncertainty.

3. Strengthen the High-End Medical Device Standard System

To improve regulatory clarity, the NMPA proposes to:

Accelerate the release of standards for innovative high-end medical devices, such as exoskeleton robots and radionuclide imaging equipment.
Promote standardisation of novel biomaterials such as brain-computer interface flexible electrodes and gene-engineered materials.
Establish an AI medical device standardisation organization.

4. Clarify Device Registration and Review Requirements

To adapt oversight to rapid technological change, proposals include:

Waiving complex change registrations for products with improved performance but unchanged core algorithms.
Simplifying review and approval processes for AI software with equivalent platforms.

5. Provide More Proactive Regulatory Services

To support innovation earlier in development, the NMPA intends to:

Establish early communication mechanisms.
Expand the expert database in clinical, material, and device fields.
Pilot the pre-registration system verification and phased inspections.

6. Implement Targeted Post-Market Regulation

To reinforce oversight after approval, the measures call for:

Develop specific inspection points for surgical robots and AI medical devices.
Build a national inspector team for high-end medical devices.
Enhance capability verification for provincial inspection institutions.

7. Enhance Post-Market Safety Monitoring for Innovative Devices

To ensure stronger patient protection, regulators propose to:

Refine reporting standards for adverse events related to AI and imaging devices.
Collaborate with the Global Harmonization Working Party (GHWP) to establish an international framework for active monitoring of medical devices, such as cardiovascular implants.
Support enterprises in conducting post-market, evidence-based research.

8. Promote Industry Information Sharing

To increase transparency and industry collaboration, the NMPA plans to:

Regularly publish a list of approved high-end medical devices to the public.
Issue the "Annual Report on High-End Medical Device Scientific Regulation and Industry Development."
Establish an expert think tank mechanism for industry associations.

9. Advance Frontier Research in Regulatory Science

To stay ahead of emerging technologies, measures include:

Leveraging platforms in AI, biomaterials, and high-end equipment.
Expanding the use of real-world evidence (RWE) in regulatory decision-making.

10. Deepen Global Regulatory Collaboration

To strengthen China’s international role, the NMPA is proposing to:

Increase participation in the standard-setting organisations such as the International Medical Device Regulators Forum (IMDRF) and GHWP.
Expand the scope of medical device export certificates.
Conduct regulatory authority training.
Establish an international tracking mechanism for innovative medical products.

Opportunities for Overseas Medical Device Manufacturers

The NMPA announcement presents clear advantages for international medical device companies, including:

Faster Market Access: Streamlined approval process for AI, robotics, and brain–computer interface technologies.
Clearer Lifecycle Oversight: Greater regulatory transparency from pre-R&D communication through post-market monitoring.
Stronger Global Alignment: Smoother cross-border compliance for high-end medical devices through deeper cooperation with global regulators and standards bodies.

However, turning these regulatory opportunities into commercial success presents complex compliance challenges when navigating China’s evolving medical device regulations. To navigate this landscape and accelerate entry into China, get in touch with Cisema today.

With over 20 years of Chinese regulatory expertise, our team supports every stage—from registration and approvals to renewals and post-market surveillance—helping you achieve NMPA compliance and enter the Chinese market with confidence.

Learn more about Cisema’s services for NMPA medical device registration.