This report highlights how AI-enabled medical devices are reshaping global healthcare systems across regulation, reimbursement, and industry development, becoming a key driver of structural transformation. As traditional static regulatory approaches struggle to keep pace with the iterative nature of AI algorithms, global frameworks are shifting toward risk-based, lifecycle-oriented governance models that balance safety, effectiveness, and innovation.
Focusing on China, the report outlines a distinctive development ecosystem shaped by rich clinical scenarios, strong policy support, and industrial clustering. It emphasizes a coordinated governance approach combining central-level regulatory frameworks with local innovation, where cities such as Beijing, Shanghai, and Shenzhen are advancing data access, regulatory efficiency, and reimbursement mechanisms. Together, these efforts are fostering an integrated innovation ecosystem from R&D to commercialization.
The report also reviews global opportunities and challenges, summarizes industry practices from both multinational and Chinese companies, and provides policy recommendations to support the development of a safe, effective, and sustainable AI medical device ecosystem in China and the broader Asia-Pacific region.