China Approves World's First AI-Based Brain-Computer Interface Medical Device Standard

China's National Medical Products Administration (NMPA) on September 14 approved the country's third brain-computer interface medical device standard, and the world's first such standard to use artificial intelligence for processing electroencephalogram (EEG) data. The new standard will take effect on September 1, 2027.

It specifies technical requirements and testing methods for the entire process of brain-computer interface medical device data collection, processing, annotation, storage, and access, aiming to address common issues such as inconsistent dataset quality control and non-standardized construction processes.

According to the NMPA, brain-computer interface medical devices act like intelligent machines that can interpret brain signals. They require learning from large amounts of EEG data and training AI algorithms to accurately understand patient intentions, which is closely related to treatment outcomes and patient safety.

To support major innovation in this field and meet urgent industrial needs, the NMPA used a fast-track procedure for project approval. The standard provides a unified quality benchmark for EEG datasets in the development and production of brain-computer interface medical devices, reaching an internationally advanced level.