提供统一权威“通用语言” 我国首部脑机接口医疗器械标准发布

Core Viewpoint - The National Medical Products Administration (NMPA) has approved the implementation of the first industry standard for brain-computer interface (BCI) medical devices in China, set to take effect on January 1, 2024, positioning China as a leader in this field internationally [1][6]. Summary by Relevant Categories Definition and Scope of BCI - The new standard defines "brain-computer interface" as a medical device capable of real-time decoding neural signals from the central nervous system, facilitating bidirectional information exchange between patients and external devices to improve or replace certain physiological functions [1][3][5]. Standardization and Regulatory Support - The standard provides a unified language for product development, production inspection, registration review, and regulation, covering core terms related to BCI medical devices, including paradigm types, signal forms, and signal processing [3]. - NMPA is expediting the establishment of multiple related standards and supportive policies to foster rapid development in the BCI medical device industry, with three additional standards already in the pipeline [9][11]. Market Growth and Future Projections - The BCI market in China is projected to exceed 6 billion yuan by 2028, with an estimated compound annual growth rate (CAGR) of 17.7% from 2024 to 2028. The global market for BCI applications in healthcare is expected to reach $40 billion by 2030 and $145 billion by 2040 [12].