国家药监局:《采用脑机接口技术的医疗器械范式设计与应用规范运动功能重建》等2项医疗器械行业标准立项
Mei Ri Jing Ji Xin Wen·2026-01-28 06:04

Core Viewpoint - The National Medical Products Administration (NMPA) has approved the establishment of two industry standards for medical devices utilizing brain-computer interface (BCI) technology to promote high-quality development in this sector [1] Group 1: Regulatory Developments - The NMPA has initiated the revision of two key standards: "Design and Application Specifications for Medical Devices Using Brain-Computer Interface Technology for Motor Function Rehabilitation" and "Reliability Verification Methods for Invasive Devices Using Brain-Computer Interface Technology" [1]

国家药监局:《采用脑机接口技术的医疗器械范式设计与应用规范运动功能重建》等2项医疗器械行业标准立项 - Reportify