The National Medical Products Administration issued two guidance documents—Guidance on Classification and Delimitation of Brain–Computer Interface Medical Devices and Guidance on Generic Naming of Brain–Computer Interface Medical Devices—to strengthen supervision and support high-quality industry development. The classification guidance requires products that use BCI technology but are not regulated as medical devices to explicitly state "not for medical purposes" and prohibits claims that they

2026-06-30

The National Medical Products Administration issued two guidance documents—Guidance on Classification and Delimitation of Brain–Computer Interface Medical Devices and Guidance on Generic Naming of Brain–Computer Interface Medical Devices—to strengthen supervision and support high-quality industry development. The classification guidance requires products that use BCI technology but are not regulated as medical devices to explicitly state "not for medical purposes" and prohibits claims that they improve, repair or replace central nervous system functions to prevent misunderstanding or exaggerated publicity.