China releases world's first standard for AI-powered brain-computer interface medical devices

China's National Medical Products Administration (NMPA) on Monday approved and issued the world's first product standard for brain-computer interface (BCI) medical devices that use artificial intelligence (AI) technology to process electroencephalogram (EEG) data.

The new standard will officially take effect on September 1 next year.

The standard systematically defines technical requirements and testing methods for the full lifecycle of BCI medical device data, including data acquisition, processing, annotation, storage and access, which helps companies address common challenges in the sector, such as inconsistent dataset quality control criteria and non-standardized dataset construction processes.

The NMPA said that BCI medical devices are like intelligent machines that can "read" brain signals. By learning from large volumes of EEG data and training AI algorithms, they can accurately interpret patients' intentions. The quality and reliability of such data are critical not only to treatment effectiveness but also to patient safety.

To support major innovations in China's BCI medical device sector and meet urgent industry development needs, the NMPA adopted an expedited process for the development and approval of the new standard. The standard provides a unified quality benchmark for EEG datasets used in the research, development and manufacturing of BCI medical devices, reaching a world-leading level.