China’s National Medical Products Administration (NMPA) on Monday approved the release of its third medical device standard for brain-computer interfaces (BCIs), which is also the world’s first medical device product standard for BCIs that uses artificial intelligence (AI) technology to process brain electrical signal data. The new standard will officially take effect on September 1, 2027, China Central Television (CCTV) reported on Monday.
According to Wang Peng, an associate research fellow at the Beijing Academy of Social Sciences, the core significance of this standard lies in establishing a unified “quality benchmark” for EEG datasets across the industry, helping drive more standardized and high-quality industry development in multiple ways.
The new standard systematically sets out technical requirements and testing methods for the entire data-handling process of BCI medical devices, covering data collection, processing, annotation, storage and access. It will help companies address common challenges in the sector, including inconsistent quality-control standards for datasets and non-standardized dataset development processes, according to the report.
