The Ministry of Health, Labor and Welfare (MHLW) on December 18 presented a proposal to define the scope of products…
REGULATORY
Japan Unveils 2nd Package Strategy for SaMD
The Ministry of Health, Labor and Welfare (MHLW) on September 6 presented its second package strategy for fueling the practical application of software as a medical device (SaMD), dubbed “DASH for SaMD 2”. The strategy revealed the MHLW’s plan to…
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