Long-listed products (LLPs) in Japan will be subject to a new health coverage scheme starting this October. This is expected…
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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