Verified75% confidenceFactExact time
Under the major global regulatory frameworks, medical AI products are classified as Software as a Medical Device (SaMD); the U.S. FDA requires clearance through the 510(k) or PMA process, China's NMPA requires completion of Class III medical device registration, and the EU regulates them through the MDR.
3
Sources
75%
Confidence
Long-term
Relevance
7/13/2026
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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