国家药监局：计划对两项脑机接口相关医疗器械行业标准立项

Core Viewpoint - The National Medical Products Administration (NMPA) has announced the initiation of two recommended industry standards for medical devices utilizing brain-computer interface technology, focusing on reliability verification methods and design/application specifications for invasive devices [1] Group 1: Industry Standards - The two proposed standards are titled "Reliability Verification Methods for Invasive Medical Devices Using Brain-Computer Interface Technology" and "Design and Application Specifications for Movement Function Reconstruction Using Brain-Computer Interface Technology" [1] - These standards are categorized as recommended industry standards, indicating a push towards formalizing guidelines in this emerging field [1] Group 2: Public Feedback - The NMPA has opened a public feedback period for any objections regarding the proposed standards, encouraging stakeholders to communicate their concerns [1]