Case Study 19 : Renewal of Foreign Manufacturer Accreditation (FMA/FMR) in Japan

Company Situation

A US based Medical Device company leader in the development and manufacture of surgical medical devices, had to renew urgently the FMA (Foreign Manufacturing Site accreditation) certificate with PMDA in Japan, as its FMA was expired already, to be able to continue to sell its medical devices in Japan.

GRP Solution

For the original FMA application, it takes PMDA 5 months to review it and provide FMA certificate to the medical device manufacturer. The renewal of FMA should be submitted to PMDA at least 30 days before its expiration.

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Aerial view of Tokyo cityscape with Fuji mountain in Japan, Tokyo

Japan's PMDA

In Japan, The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects. The PMDA operates under the Ministry of Health, Labor, and Welfare (MHLW) .These two government organization both handle a wide range of activities, from approval reviews to post-market surveillance.