The National Medical Products Administration today (the 14th) approved and released China's third brain-computer interface medical device standard, which is also the world's first brain-computer interface medical device product standard that uses artificial intelligence technology to process electroencephalogram data. The new standard will officially take effect on September 1 next year.

It is understood that the new standard systematically specifies the technical requirements and testing methods for the entire process of brain-computer interface medical devices, including data collection, processing, annotation, storage, and access, helping enterprises address common issues such as inconsistent quality control standards for datasets and non-standardized construction processes in brain-computer interface medical devices.

The National Medical Products Administration stated that brain-computer interface medical devices are like intelligent machines that can "read" brain signals. They need to "learn" from large amounts of electroencephalogram data and "train" artificial intelligence algorithms to accurately understand patients' intentions. This not only affects treatment outcomes but is also closely related to patient safety risks.

In order to support major innovations in China's brain-computer interface medical devices and meet the urgent needs of industry development, the National Medical Products Administration adopted a fast-track procedure for project initiation and approval. The new standard provides a unified "quality yardstick" for electroencephalogram datasets in the research and development and production of brain-computer interface medical devices, reaching an internationally leading level.