The General Administration of Market Supervision has approved the establishment of a national intelligent medical device standardization working group.

Recently, the State Administration for Market Regulation approved the establishment of the National Standardization Working Group for Smart Medical Devices, which will be managed by the National Medical Products Administration. The National Standardization Working Group for Smart Medical Devices will be responsible for the standardization of smart medical devices nationwide, including artificial intelligence medical devices, medical robots, brain-machine interface medical devices, and medical devices in the field of integrated technologies. The establishment of this working group is in line with the urgent needs of national strategy and industrial development, and it aligns with the development trend of the deep integration of new technologies such as artificial intelligence, medical robots, and brain-machine interfaces with medical devices. This working group will effectively fill the gap in standardization technology organizations in the field of smart medical devices in China, further improving the layout of the medical device standard system. In the next step, the State Administration for Market Regulation will work together with the National Medical Products Administration to accelerate the construction of a comprehensive, scientifically standardized, and internationally aligned standard system for smart medical devices, guiding the industry towards high-quality development with high standards, and helping China progress from a major medical device country to a stronger medical device nation.