Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
MHLW Launches New Office to Fuel SaMD Commercialization
The Ministry of Health, Labor and Welfare (MHLW) on April 1 established a new office to propel the commercialization of software as a medical device (SaMD) in Japan, such as therapeutic apps and diagnostic imaging software. SaMD is defined by…
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