China: China has approved the issuance of the country's third medical-device standard for brain-computer interfaces (BCIs), which also marks the world's first such standard for BCI medical devices using artificial intelligence (AI) to process brain activity data. BCI technology enables direct communication between the brain and external devices, paving the way for new medical and technological applications. By capturing and decoding neural signals, BCI enables seamless interaction between the brain and the machine, ultimately allowing control over assistive devices to execute intended actions.
According to Qatar News Agency, the standard issued by the National Medical Products Administration (NMPA) outlines quality requirements and evaluation methods for electroencephalogram (EEG) datasets used by artificial intelligence algorithms in Brain-Computer Interface (BCI) medical devices. It applies to datasets utilized across various stages-including research and development, production, and quality control-of BCI medical device technologies that employ AI algorithms to process EEG signals.
AI-powered BCI devices rely on large, high-quality EEG datasets to train algorithms to decode brain signals and identify patient intentions. In medical applications, the quality and integrity of this data can directly impact device performance and safety, NMPA said. China had previously issued two BCI medical-device standards in 2025, covering terminology and test methods for the sensing and response performance of implantable neural stimulators with closed-loop functions. The new standard will take effect on Sept. 1, 2027.