The Ministry of Health, Labor and Welfare (MHLW) on December 18 presented a proposal to define the scope of products…
COMMENTARY
With 2nd Strategy Penned, Can Japan Play Catch-Up with US & Europe in SaMD Push?
In early September, Japan released its second package strategy for software as a medical device (SaMD), dubbed “DASH for SaMD 2”. With new measures added to its first edition compiled in 2020, the new strategy embraces “predictability” and “international expansion”…
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