Japan Pharmaceutical and Medical Device Act (PMD Act) regulation
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 can help you understand device classifications, prepare for the
review process, and help you meet standards.
Join our complementary webinar to find out about JPMDAct (Japan Pharmaceutical and
Medical Device Act) and the differences from the former JPAL, and what is the impact to
manufactures outside Japan.
Seiko Oyama since ISO 9001 had been first introduced in Japan in 1990,
Seiko was in charge of the operation of ISO 9001 training courses led by BSI instructors
based in the UK. After succeedingd in implementing IRCA accredited ISO 9001 lead auditor
training courses to Japan, Seiko implemented and operated JAB (later JRCA) accredited
lead auditor training courses.