On 6 May 2026, the State Administration for Market Regulation (SAMR) approved the establishment of the National Intelligent Medical Equipment Standardization Working Group (SWG), delegating its management to the National Medical Products Administration (NMPA). The official SWG number has not be finalized and announced to the public.
The SWG is primarily responsible for nationwide standardization in intelligent medical devices, encompassing AI-enabled medical devices, medical robots, brain-computer interface medical devices, and convergent technology medical devices.
The establishment of this working group aligns with national strategic priorities and the urgent needs of industrial development. It responds to the accelerating convergence of emerging technologies such as artificial intelligence, medical robotics, and brain-computer interfaces with medical devices.
Under the Measure for the Administration of the China National Standardization Technical Committee, a standardization working group that has operated for three full years and received technical committee conversion approval from the relevant State Council department becomes eligible for establishment as a formal technical committee.
The next three years will be critical to the working group’s long-term viability. It must demonstrate its capacity to effectively address the existing gap in standardization technical organizations for intelligent medical devices in China, thereby further strengthening the medical device standard system architecture. SESEC will monitor the progress of this new working group.
