Foreign Manufacturer Accreditation for Medical Device Companies Exporting to Japan

See all regulatory consulting services.

Manufacturing facilities located within Japan must be licensed and need to possess a Manufacturer License (“Kyoka” for manufacturing). If the manufacturing facilities are located outside Japan, manufacturers are required to obtain a Foreign Manufacturer Accreditation instead of a Manufacturer License.

The following documents must be prepared for the application and submitted to the PMDA and Emergo Japan can assist in compiling and coordinating these documents for you.

• Application for medical device Foreign Manufacturer Accreditation in Japan (Form No. 18)
• Supporting Documentation (medical certificate, product list, summary of building and facilities etc.)
• Registration form to obtain a manufacturing code

Emergo Group, with offices in Tokyo, can fully assist in preparing the Foreign Manufacturer Accreditation application which is filed with PMDA by the MAH, and we can submit this application even if you have not appointed Emergo Japan as your D-MAH.

Please contact us for more information or a free proposal for obtaining Foreign Manufacturer Accreditation for medical device companies selling in Japan.