Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
MHLW Notification Outlines 2-Stage Approval Scheme for SaMD
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on November 16 explaining the basic concepts and target products of the two-step approval rule for software as a medical device (SaMD). The notification calls on companies considering strategies…
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