The State Drug Administration today approved the release of China's third brain-computer interface medical device standard. It is also the world's first brain-computer interface medical device product standard using artificial intelligence technology to process EEG data. The new standard will be officially implemented on September 1 next year. According to our understanding, the new standard system regulates technical requirements and test methods for the entire process of data collection, processing, labeling, storage, and access for brain-computer interface medical devices, and helps enterprises solve common problems such as inconsistent quality control scales in data sets and irregular construction processes. The State Drug Administration said that a brain-computer interface medical device is like an intelligent machine that can “read” brain signals. It needs to “learn” large amounts of EEG data and “train” artificial intelligence algorithms to accurately understand patients' intentions. This is not only related to treatment efficacy, but also closely related to patient safety risks. In order to support major innovations in brain-computer interface medical devices in China and meet the urgent needs of industrial development, the State Drug Administration adopted a rapid procedure to establish and approve the project. The new standard provides a unified “quality scale” for the R&D and production of brain-computer interface medical devices, reaching the leading international level.

The State Drug Administration today approved the release of China's third brain-computer interface medical device standard. It is also the world's first brain-computer interface medical device product standard using artificial intelligence technology to process EEG data. The new standard will be officially implemented on September 1 next year. According to our understanding, the new standard system regulates technical requirements and test methods for the entire process of data collection, processing, labeling, storage, and access for brain-computer interface medical devices, and helps enterprises solve common problems such as inconsistent quality control scales in data sets and irregular construction processes. The State Drug Administration said that a brain-computer interface medical device is like an intelligent machine that can “read” brain signals. It needs to “learn” large amounts of EEG data and “train” artificial intelligence algorithms to accurately understand patients' intentions. This is not only related to treatment efficacy, but also closely related to patient safety risks. In order to support major innovations in brain-computer interface medical devices in China and meet the urgent needs of industrial development, the State Drug Administration adopted a rapid procedure to establish and approve the project. The new standard provides a unified “quality scale” for the R&D and production of brain-computer interface medical devices, reaching the leading international level.