Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
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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