Regulators Compare US, Japan Approaches To Digital Health

A discussion of Japanese and American digital health regulations at CRT2023 in Washington, DC, explored the similarities between the two countries and how we regulate software and connected devices.

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The digital health revolution is taking the world by storm, and Japan and America have similar ways of regulating the growing industry, Japanese officials explained at an FDA-Japan session during the Cardiovascular Research Technologies 2023 conference in Washington, DC, on 27 February.

Japan and America have long collaborated on medical device regulations. The US-Japan Medical Device Harmonization by Doing program was established in December 2003. The working group is a collaboration...

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