Japan PMDA - Pharmaceuticals and Medical Devices Agency

The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in Japan that is in charge of reviewing drugs and medical devices, deals with post-market safety and provides relief for adverse health effects. The PMDA in its current form exists since 2004, when it was formed by incorporating the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR/KIKO), and part of the Japan Association for the Advancement of Medical Equipment (JAAME).

The PMDA is part of the Ministry of Health, Labor, and Welfare (MHLW) and they both handle a wide range of activities, from approval reviews to post-market surveillance. Within the PMDA, the Office of Medical Devices Evaluation supervises the manufacturing of medical devices, enforces standards and grants approval to manufacture and market devices.

Major Regulations

Some of the most important regulations for medical devices in Japan are:

A full list of PMDA regulations can be found here.

Contact details:

Medical Device Associations in Japan: