China has officially issued the first medical device standard for brain-computer interface (BCI). The new standard, which has been given the identifier YY/T 1987-2025, represents a significant milestone in controlling and shaping one of its most cutting-edge fields: health care and A.I. It will go into effect in January 2026.
The standard gives clear definitions and guidelines of how BCIs should be developed and used. It includes signal modalities, processing approaches, BCI paradigms and medical applications. By establishing a single framework, China aims to minimize confusion in research and production, guarantee safety and promote innovation.
Experts have said for years that the absence of a standard vocabulary has prevented BCI devices from gaining broader traction. Companies, researchers and regulators sometimes found it difficult to communicate with one another. This standard now solves that issue by establishing the same language for everyone to use. It aims to make medical devices more trustworthy and enable new products to pass through testing and approval processes more quickly.
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This is just the start, officials have emphasized. China is to formulate a comprehensive standard system that will regulate all stages from design and testing through to after-market supervision of BCI devices. The challenge is to do so while keeping devices safe, effective and worthy of public trust — ensuring that patients benefit from real advances in care.
