Gain market access in Japan with PMD Act and PMDA approval

Pharmaceutical and Medical Device Act (PMD Act) regulation

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The distribution of medical devices in Japan is regulated in accordance with the Pharmaceutical and Medical Device Act (PMD Act) Regulation by the Ministry of Health, Labour and Welfare (MHLW).  The former Regulation, Japanese Pharmaceutical Affairs Law (JPAL) was replaced by PMD Act on November, 25, 2014. The revision includes third party certification systems for Class III medical devices and expansion of the responsibility of quality management system to legal manufactures.

Because of the complexities of PMD Act and the involvement of Japanese and international governmental bodies, we have developed resources to explain device classification, the review process and the required standards.