China Releases World's First AI Brain-Computer Interface Medical Device Standard

China's National Medical Products Administration has approved a new standard for brain-computer interface medical devices. It is China's third such standard and the world's first product standard for brain-computer interface medical devices that uses artificial intelligence to process brainwave data. The new standard will take effect on September 1, 2026.

The standard sets technical requirements and testing methods for the full process of brain-computer interface medical devices, including data collection, processing, labeling, storage, and access. It aims to solve common problems in the industry, such as inconsistent data quality control and non-standard development processes.

Brain-computer interface medical devices need to learn from large amounts of brainwave data and train AI algorithms to accurately understand patients' intentions. Data quality directly affects treatment results and patient safety. The National Medical Products Administration used a fast-track process to approve the standard, providing a unified quality benchmark for brainwave datasets in the research and production of these devices, reaching an internationally leading level.