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On September 14, 2026, the National Medical Products Administration gave its official nod and rolled out China's third medical device standard tailored specifically for brain-computer interfaces. This groundbreaking standard stands as the world's inaugural medical device product standard for brain-computer interfaces, harnessing the power of artificial intelligence to process brainwave data. It is set to take effect on September 1, 2027. The newly established standard meticulously outlines the technical specifications and testing protocols for every stage of brain-computer interface medical devices, encompassing data acquisition, processing, labeling, storage, and access. This comprehensive framework will assist companies in overcoming prevalent challenges, such as inconsistent dataset quality control standards and non-standardized construction workflows.
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