医用穿戴式脑电设备技术审评规范分析

Technical Evaluation Standard Analysis of Medical Wearable Electroencephalogram Devices

医用穿戴式脑电设备具有硬件集成度高、智能化程度高、便携性好、可长期实时监测等特点,已成为国内外关注的热点。但该产品与传统的脑电图机有很大不同,而且缺少相应的标准、规范,致使产品注册上市、质量控制均存在一定难度。本文从技术审评角度出发,围绕技术审评工作中的主要关注点,如产品结构组成、主要风险、性能要求、临床评价等,开展详细阐述及分析,以期为该产品的设计开发、生产、注册、使用、上市后监管提供依据。

The medical wearable electroencephalogram(EEG)devices with high integration,high intelligence,good portability,long-term and real-time monitoring and other characteristics has become a research hot spot at home and abroad.But this product is very different from the traditional EEG devices,because it is short of the corresponding standards and norms,resulting in product registration and marketing,quality control are difficult.From the perspective of technical evaluation,this paper focused on the main concerns of technical review,such as product structure,main risks,performance requirements,clinical evaluation,etc.to carry out detailed elaboration and analysis,in order to provide guidance for the design and development,production,registration,use and post-market supervision of the devices.