New regulations falls into place and implemented on October 1, 2027

Recently, the National Medical Products Administration issued an announcement stating that the medical device industry standard YY/T 1996—2025 “Testing Methods for Sensing and Response Performance of Implantable Neural Stimulators with Closed-Loop Function Using Brain-Computer Interface Technology” has been reviewed and approved and is now promulgated.

This standard document describes the testing methods for the sensing and response performance of implantable neurostimulators with closed-loop functionality using brain-computer interface technology based on neural signals, and is applicable to implantable neurostimulators with closed-loop functionality that adopt brain-computer interface technology.

Medical Device Industry Standard Information Form

According to the announcement, the implementation date of this standard is October 1, 2027.

As a cutting-edge technology, brain-computer interface can decode the neural signals generated by the central nervous system in real time, helping patients achieve real-time two-way information interaction or closed-loop feedback with external auxiliary or diagnostic equipment, thereby improving, repairing or replacing patients’ physiological functions.

The release of this standard coincides with the period of rapid growth in China’s brain-computer interface market.

It is worth noting that in addition to the performance testing method standard released this time, the National Medical Products Administration has recently approved and issued the industry standard “Terminology for Medical Devices Using Brain-Computer Interface Technology”, which is China’s first standard for brain-computer interface medical devices.

The terminology standards will be officially implemented on January 1st next year, providing a unified and authoritative “common language” for product research and development, production inspection, registration evaluation, and supervision.

At present, three standards for brain-computer interface medical devices have been approved for project establishment and formulation through an accelerated procedure, with a focus on areas such as “electroencephalogram datasets for artificial intelligence algorithms” and “motion intention encoding and decoding performance”.

The National Medical Products Administration has established a working group for standard system research, proposed a list of relevant standards to be prioritized for formulation in the next 3-5 years, and strived to cover the whole life cycle management of brain-computer interface medical device products.

The global market size of brain-computer interfaces in medical applications is expected to reach 40 billion US dollars by 2030 and may reach 145 billion US dollars by 2040. With the continuous improvement of technical standard systems, brain-computer interface technology will gradually expand to more medical fields, bringing new treatment options to patients with related diseases.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

By Cai Zhong She

Translated & edited：Bradyknown