中国人工智能医疗器械软件的监管框架:对全球制造商的影响进行比较分析和审查
Yu Han1, Aaron Ceross1, Jeroen Bergmann1,2
1University of Oxford, Oxford, United Kingdom.
JMIR AI
|July 29, 2024
概括
中国中国中国中国.
科学领域:
- 医疗器械监管法规 医疗器械监管法规
- 医疗信息学 医疗信息学
- 医疗保健中的人工智能
背景情况:
- 中国国家人工智能 (AI) 战略促进了包括医疗保健在内的各个部门的AI整合.
- 中国是医疗器械的主要生产国和消费国,医疗保健软件注册量激增.
- 现有的监管框架要求对医疗器械软件进行审查,特别是支持人工智能的解决方案.
研究的目的:
- 分析中国医疗器械软件的监管环境.
- 将中国的法规与美国和欧洲的法规进行比较.
- 确定医疗保健软件中人工智能和机器学习的监管挑战.
主要方法:
- 关于中国医疗器械软件 (SaMD和SiMD) 监管框架的概述.
- 对中国,美国和欧洲的AI/ML医疗器械法规进行比较分析.
- 识别监管挑战和指导需求.
主要成果:
- 中国医疗保健软件开发的大幅增长需要加强监管指导.
- 对于AI/ML医疗器械,在中国,美国和欧洲存在着不同的监管框架.
- 人工智能/ML领域的快速发展带来了独特的监管挑战.
结论:
- 中国不断发展的医疗器械软件监管框架需要注意,尤其是国际制造商.
- 了解区域监管差异对于全球市场准入至关重要.
- 解决AI/ML特定挑战对于未来的医疗软件创新和合规至关重要.
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