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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.

read1 min views3 publishedSep 15, 2026
China issues first AI-plus-brain-computer interface medical-device standard
Image: Technode (auto-discovered)

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, in Chinese]

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