Japanese regulation and approval process for medical artificial intelligence (AI) as software as a medical device (SaMD): Current status and emerging challenges

Global Health and Medicine · Published 2026-06-18 · DOI 10.35772/ghm.2026.01052

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Authors (5)

Sara Takahashi, Tomohiko Makino, Reiko Mizutani, Takanori Hirano, Yumiko Nomura

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Publication details

Year

2026

Citation

Takahashi, S., Makino, T., Mizutani, R., et al. (2026). Japanese regulation and approval process for medical artificial intelligence (AI) as software as a medical device (SaMD): Current status and emerging challenges. Global Health and Medicine. https://doi.org/10.35772/ghm.2026.01052

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