China issues first standard for AI-brain-computer interface medical devices
China's National Medical Products Administration has approved a new industry standard for EEG dataset quality and evaluation methods for AI algorithms in brain-computer interface devices. The standard takes effect September 1, 2027.
China's National Medical Products Administration (NMPA) has issued the country's first industry standard for medical devices that integrate artificial intelligence (AI) with brain-computer interfaces (BCI).
The new standard, YY/T 2029–2026, outlines data quality requirements and evaluation methods for electroencephalography (EEG) datasets used by AI algorithms in BCI devices. It covers aspects such as data collection, processing, labeling, storage, and access.
The standard aims to establish a consistent quality baseline for research, manufacturing, testing, and regulation within the BCI medical device sector. This initiative is intended to ensure the reliability and safety of technologies that facilitate communication and control through brain signals.
This new standard is scheduled to take effect on September 1, 2027. Its implementation is expected to support the advancement of BCI technology and ensure data integrity in a rapidly evolving field.