The Ministry of Health, Labor and Welfare (MHLW) on December 18 presented a proposal to define the scope of products…
REGULATORY
Chuikyo Subcommittee OKs Basic SaMD Reimbursement Rule
The Central Social Insurance Medical Council’s (Chuikyo) medical materials subcommittee basically approved the outlines of the evaluation rules for software as a medical device (SaMD) under health insurance programs on November 12. Based on examples in the past, SaMD that…
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