Aug 4, 2011

The Japan Federation of Medical Device Associations (JFMDA) has filed a petition with the country’s Ministry of Health, Labour and Welfare as well as the Pharmaceutical and Medical Devices Agency (PMDA) arguing for more flexible accreditation requirements for foreign device manufacturers that move factories or change names due to mergers or acquisitions.

According to, current law requires foreign manufacturers that relocate factories or change corporate identities to resubmit requests for accreditation. Until those firms are reaccredited, they cannot export products to Japan.

The JMDA has argued that these firms should only have to register their company names, locations and the names of their representatives in order to obtain reaccreditation. Currently, manufacturers must undergo new factory inspections including quality system audits as part of the Japanese reaccreditation process.

Easing the reaccreditation process for foreign medical device manufacturers would provide a more stable supply of medical devices in Japan, contends the JMDA. The association filed the petition as the Japanese government considers how to amend its Pharmaceutical Affairs Law in 2012.

Given that Japan is both one of the largest and most complex medical device markets, any effort to make this market more accessible without compromising safety warrants serious consideration.


  • Stewart Eisenhart