The National Medical Products Administration issued the new standard YY/T 1996—2025 for brain-computer interfaces

On September 28, 2025, the National Medical Products Administration released the standard YY/T 1996—2025, which describes the testing methods for the sensing and response performance of implantable neurostimulators that adopt brain-computer interface technology and have closed-loop functions. This standard will come into effect on October 1, 2027.As a cutting-edge technology, brain-computer interfaces can improve, repair, or replace patients’ physiological functions. The release of this standard coincides with the period of rapid growth in China’s brain-computer interface market, and it is expected that the market size will exceed 6 billion yuan by 2028.In addition, the National Medical Products Administration has also approved and released the first terminology standard for brain-computer interface medical devices, which will come into effect on January 1 next year. At present, three related standards have been initiated for formulation, with a focus on aspects such as EEG datasets and the performance of motion intention encoding and decoding. The National Medical Products Administration has set up a working group and proposed a list of standards to be prioritized for formulation in the future, covering the whole life cycle management of products. As standards improve, brain-computer interfaces will expand into more medical fields.