Japan market access

Pharmaceutical and Medical Device Act (PMD Act) regulation

Japan market accessThe 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 can help you understand device classifications, prepare for the review process, and help you meet standards.

Download our brochure to learn more about the Japanese market entry requirements, and how BSI can support you.