China Releases First Industry Standard for Brain-Computer Interface Medical Devices
On September 16, China’s National Medical Products Administration officially approved and released the country’s first industry standard specifically designed for brain-computer interface (BCI) medical devices. Titled 'Terminology of Medical Devices Using Brain-Computer Interface Technology,' this new regulation establishes standardized definitions and concepts for BCI-based medical equipment. The standard is scheduled to take effect on January 1, 2026, with the primary goal of supporting the long-term development and规范化 of the emerging BCI sector. This regulatory milestone follows a broader policy framework issued in August by seven Chinese government departments. That earlier framework set ambitious targets for achieving breakthroughs in key BCI technologies by 2027. Furthermore, it outlined strategic goals to build industrial clusters, expand practical applications, and foster globally competitive companies within the BCI industry by 2030. This move signifies China's structured approach to regulating and advancing neurotechnology, aiming to balance innovation with safety and standardization in medical device manufacturing.
Wire timeline
China Releases First Industry Standard for Brain-Computer Interface Medical Devices
On September 16, China’s National Medical Products Administration officially approved and released the country’s first industry standard specifically designed for brain-computer interface (BCI) medical devices. Titled 'Terminology of Medical Devices Using Brain-Computer Interface Technology,' this new regulation establishes standardized definitions and concepts for BCI-based medical equipment. The standard is scheduled to take effect on January 1, 2026, with the primary goal of supporting the long-term development and规范化 of the emerging BCI sector. This regulatory milestone follows a broader policy framework issued in August by seven Chinese government departments. That earlier framework set ambitious targets for achieving breakthroughs in key BCI technologies by 2027. Furthermore, it outlined strategic goals to build industrial clusters, expand practical applications, and foster globally competitive companies within the BCI industry by 2030. This move signifies China's structured approach to regulating and advancing neurotechnology, aiming to balance innovation with safety and standardization in medical device manufacturing.
TechNode