JPAL Regulatory Services


As of 25 November 2014, the Japanese Pharmaceutical Affairs Law (also known as PAL) was revised, with its title changed to the "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics" (abbreviated as the PMD Act).

The PMD Act provides the legal framework for the regulation of medical devices, in vitro diagnostic reagents, pharmaceuticals, drugs and cosmetic products as well as regenerative and cellular therapy products in the Japanese market.

Because of the complexities of the PMD Act and the involvement of Japanese and international certification /notified body, DEKRA can help you understand device classifications, prepare for the review process, and help you meet standards.

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