Dear Editor,

In recent years, China has introduced new regulatory changes for medicine as well as AI X Medical devices. A focus is to use AI and digital technologies to enhance oversight and efficiency. The National Medical Products Administration (NMPA) has adopted AI-powered systems for real-time quality monitoring, automated adverse event tracking, and faster drug approval processes. Machine learning algorithms now assist in analyzing clinical trial data, optimizing formulations, and detecting counterfeit products. Additionally, AI technology is being explored for secure supply chain traceability by the State Administration for Market Regulation (SAMR), which is involved as medical devices is also labeled as a kind of consumer good. These advancements align with China’s broader push for “smart regulation” under initiatives such as Healthy China 2030. The integration of AI has not only streamlined approvals but also positioned China as a leader in tech-driven medical and pharmaceutical regulations (Weinreb, Lee, Baxter, et al., 2025).

Indeed, with multiple complex faces, medical devices remain an attractive topic for scholarships from different fields. In the historical evolution of the sector, the active role of medical devices has been proven in the market revolution in early America. In the Asian context, medical research was presented as a valuable lens for better understanding the interaction among science, technology, and society. Throughout its history and development, therapeutics have also been closely associated with cross-cultural exchanges and medical pluralism. It is therefore needed for us to acknowledge the multiple role of medical devices as well as other medicine in the new regulatory landscape under the era of AI.

Reference

Weinreb RN, Lee AY, Baxter SL, et al. Application of Artificial Intelligence to Deliver Healthcare From the Eye. JAMA Ophthalmol. 2025;143(6):529–535. doi:10.1001/jamaophthalmol.2025.0881