The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
SaMD Could Be Eligible for 2-Stage Approval System: MHLW
The current two-step approval scheme allowed for certain medical devices can be also applied to software as medical device (SaMD), the Ministry of Health, Labor and Welfare (MHLW) said on May 30. The MHLW expressed this view during a session…
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