China launches global ai-integrated brain-computer interface standard

On September 14, 2026, the National Medical Products Administration (NMPA) approved the release of China's third brain-computer interface (BCI) medical device standard. This marks the first global standard that integrates artificial intelligence to process electroencephalogram (EEG) data for BCI devices, set to take effect on September 1, 2027. The standard outlines technical requirements and testing methods for data collection, processing, annotation, storage, and access in BCI medical devices, addressing issues such as inconsistent data quality and non-standardized development processes. The NMPA emphasized that BCI devices function as intelligent machines capable of interpreting brain signals. These devices require extensive training with EEG data and AI algorithms to accurately interpret patient intent, which is critical for both treatment efficacy and patient safety. The new standard supports major innovations in China's BCI medical devices and meets urgent industry needs by providing a unified 'quality benchmark' for EEG datasets, achieving international leadership in the field.