China issues first AI-plus-brain-computer interface medical-device standard

China's National Medical Products Administration approved YY/T 2029–2026, the country's first medical-device industry standard for artificial-intelligence algorithms used in brain-computer interface devices, covering EEG dataset quality requirements and evaluation methods. The standard addresses data collection, processing, labeling, storage and access to set a consistent quality baseline for research, manufacturing, testing and regulation, and takes effect on Sept. 1, 2027.

China’s National Medical Products Administration has approved YY/T 2029–2026, a medical-device industry standard covering EEG dataset quality requirements and evaluation methods for artificial-intelligence algorithms used in brain-computer interface devices. The standard covers data collection, processing, labeling, storage and access, and is intended to provide a consistent quality baseline for research, manufacturing, testing and regulation. It is scheduled to take effect on Sept. 1, 2027. China Food and Drug News https://cnpharm.cn/c/2026-09-14/1106753.shtml , in Chinese