China’s National Medical Products Administration (NMPA) issued a new strategy on July 3, 2025, to advance high-quality medical devices, including 10 regulatory measures aimed at accelerating the development of innovative medical technologies.
Key Objectives of the Strategy
Supporting the development of advanced medical devices domestically and globally
The policy prioritizes technologies with high clinical value and international leadership potential, including:
- Surgical and rehabilitation robots
- AI-powered diagnostic systems
- Advanced imaging equipment
- New biomaterials
Regulatory Improvements at Every Stage
Innovation and Classification
Specific classification guidelines have been developed for medical robots, with the formation of joint expert consensus on naming conventions.
Standards System
Accelerating standards development for technologies such as:
- Exoskeleton robots
- Nuclear medicine imaging equipment
- Biomaterials for additive manufacturing
Approval and Registration Process
- Enhanced special approval pathways for first-of-kind products in China
- Simplified change registration for AI-based products
- New evaluation standards for measuring AI performance
Communication and Consultation Mechanisms
- Enhanced guidance on product testing and clinical evaluation
- Expanded expert pool to include active device and materials science specialists
- Early-stage inspection systems and phased inspections
Implications for Foreign and Domestic Companies
For Foreign Companies:
- Simplified market access: Clearer classification guidelines and accelerated approval pathways
- Competitive advantage for joint ventures: Strong incentives for companies with robust R&D pipelines
- Favorable environment for high-tech sectors: Focus on emerging technologies aligns with global trends
Increasing Compliance Expectations:
- Stricter post-market obligations
- Risk-based inspections
- Real-world evidence collection
- Adverse event monitoring