China has introduced a new regulatory framework for brain-computer interface (BCI) medical devices, marking a significant step toward standardizing how artificial intelligence processes brain signal data for medical applications.
China’s National Medical Products Administration (NMPA) has approved its 3rd medical device standard for BCIs. The standard is also described as the world’s 1st medical device product standard for BCIs that uses AI to process brain electrical signal data. It will officially take effect on September 1, 2027.
According to Wang Peng, an associate research fellow at the Beijing Academy of Social Sciences, the standard’s key role is to establish a unified “quality benchmark” for EEG datasets and support more standardized and high-quality development across the industry.
The standard sets technical requirements and testing methods for the full data-handling process of BCI medical devices. This includes data collection, processing, annotation, storage and access.
It is also designed to address challenges such as inconsistent quality-control standards for datasets and non-standardized processes for developing them.
The NMPA explained that BCI medical devices function like intelligent systems that can “read” brain signals. They need to “learn” from large volumes of electroencephalography (EEG) data to train AI algorithms that interpret patients’ intentions. This makes data quality critical for both treatment outcomes and patient safety.
Wang said the standard strengthens patient safety by introducing unified quality requirements for EEG data used to train AI systems. Better-quality data can support more accurate brain-intent decoding, improve treatment outcomes and reduce data-related safety risks.
To support innovation in China’s BCI medical device sector and respond to industry demand, the NMPA used an expedited process to develop and approve the standard.
Wang said the framework fills a gap in international rules and places China at the forefront of BCI standard-setting. It also builds on existing terminology standards and could support future rules for more specialized BCI medical applications.
The standard is expected to help create a broader regulatory framework and accelerate the clinical translation of BCI technologies. It could also address key data-related challenges involved in the compliant commercialization of BCI products for rehabilitation and neurological disease treatment.
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