Foreign Manufacturer Accreditation (FMA) Audits for Medical Devices in Japan

The new 2005 Japanese PAL increased requirements for medical device manufacturers outside Japan. Specifically, all foreign manufacturers of Class II or higher medical devices must receive Foreign Manufacturer Accreditation (FMA), which involves an audit by Japanese regulatory officials, before their products can be registered in Japan.

The FMA process assesses a manufacturing site’s buildings and facilities in order to confirm that the foreign manufacturer is able to participate in the product registration process. Applicants submit such details as floor plans, executive organization chart, list of products made at the facility and other documents for review.

Unlike QMS audits, FMA is granted on a per-facility basis, rather than a per-product basis. Also unlike QMS audits, FMA is awarded through a separate application which is not part of the product registration application.

FMA audits are typically carried out via documentary only (paper) inspections, though there have been a few on-site inspections in the past.

For more information on Japanese quality standards, please see the following PBM publications and/or contact us to discuss your specific needs.

More on Japan

Get Sourcing/Manufacturing in Asia Consulting

Back to top