摘要
基于目前计算机辅助诊断软件产品的发展现状,结合国内外的监管现实,并根据当前的《医疗器械分类目录》和相关法规,对辅助诊断类软件产品的属性界定和管理类别划分进行了探讨和分析,对采用人工智能等新技术的辅助诊断软件类别划分原则提出了技术建议,供监管和技术部门参考。
Based on the developing situation of Computer Aided Diagnosis/Detection(CAD)software,considering the domestic and international regulation of CAD software,according to current Medical Device Classification Catalog and related laws of China Food and Drug Administration(CFDA),this paper investigated and analyzed the classification of CAD software,and provided technical suggestion on classifying principle of CAD software applying Artificial Intelligence(AI)or other advanced technology from medical device regulation scope,for the reference of regulatory and technical departments.
作者
戎善奎
江潇
冯建
张春青
余新华
RONG Shankui;JIANG Xiao;FENG Jian;ZHANG Chunqing;YU Xinhua(National Institutes for Food and Drug Control(Center for Medical Device Standardization Administration),Beijing,102629;Beijing Institute of Medical Device Testing,Beijing,101111)
出处
《中国医疗器械杂志》
2019年第5期359-361,共3页
Chinese Journal of Medical Instrumentation
关键词
计算机辅助诊断软件
人工智能
医疗器械分类
computer aided diagnosis/detection software
artificial intelligence
classification of medical device
