The State Administration for Market Regulation has approved the establishment of a national standardization working group for intelligent medical devices, which will be managed by the National Medical Products Administration. This working group will be responsible for standardization efforts in the field of intelligent medical devices, including artificial intelligence medical devices, medical robots, brain-computer interface medical devices, and integrated technology medical devices. The formation of this group aligns with national strategic priorities and urgent industry development needs, keeping pace with the trend of deep integration between new technologies—such as AI, medical robotics, and brain-computer interfaces—and medical devices. It will effectively address the gap in standardized technical organizations within China's intelligent medical device sector and further improve the overall medical device standard system. Moving forward, the State Administration for Market Regulation, in collaboration with the National Medical Products Administration, will accelerate the development of a comprehensive, scientifically sound, and internationally aligned standard system for intelligent medical devices. High standards are expected to guide the high-quality development of the industry and support China's transition from a major producer to a global leader in medical devices.