The National Medical Products Administration of China has approved the country's third medical device standard for brain-computer interfaces. This is the first global standard specifically addressing medical devices that utilize artificial intelligence to process EEG data.
The new regulation establishes comprehensive technical requirements and testing protocols for the entire lifecycle of BCI medical devices. It covers data collection, processing, annotation, storage, and access, aiming to standardize quality control for datasets used in the industry.
The standard serves as a quality benchmark for EEG datasets, which are essential for training AI algorithms to interpret brain signals accurately. The administration noted that these algorithms are critical for both the therapeutic efficacy and the safety of patients using such devices.
To accelerate the development of the sector, the regulator employed an expedited approval process. The implementation of these new requirements is scheduled to begin on September 1, 2025, providing a unified framework for domestic research and production.
