Unverified50% confidenceFactExact time
美国FDA在2021年发布《人工智能/机器学习医疗器械软件行动计划》，要求通过510(k)或PMA流程；欧盟MDR（2017/745法规）于2021年正式生效；中国NMPA于2021年发布《人工智能医疗器械注册审查指导原则》
1
Sources
50%
Confidence
Long-term
Relevance
7/14/2026
First Seen
Sources
疟疾细胞AI识别：医学影像分类实践全解析
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