Impact of recent changes to Japan’s medical device regulations: a Competent Authority perspective -

Medical devices distributed in Japan are subject to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics, which has been enforced since November 2014 and made major revisions to the Pharmaceutical Affairs Law. This article reflects on the two years that have passed since implementation of the Act, and the progress that has been made as a result of the changes. The article also looks at the recent introduction of other key regulatory activities in the medical device field by the Japanese regulatory authorities: the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency.

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