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[关于数字治疗软件分类管理的研究]
Xiao Jiang1, Chunqing Zhang1, Shankui Rong1
1National Institutes for Food and Drug Control, Beijing, 102629.
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation
|September 27, 2023
概括
这项研究提出了中国数字治疗软件的分类框架. 它旨在通过分析产品属性和国际标准来指导监管管理.
科学领域:
- 数字健康数字健康
- 医疗器械监管法规 医疗器械监管法规
- 软件作为医疗设备 (SaMD)
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