The Ministry of Health, Labor and Welfare (MHLW) on December 18 presented a proposal to define the scope of products…
COMMENTARY
Public-Private Collaboration Needed to Refine SaMD Regulatory System
A year has passed since the Ministry of Health, Labor and Welfare (MHLW) announced its package strategy to fuel the early commercialization of software as a medical device (SaMD) in November last year. A growing number of drug makers are…
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