FMA Support Services
What is the FMA (Foreign Manufacturers Accreditation) ?
A foreign manufacturer intending to manufacture drugs, quasi-drugs, or medical devices in foreign countries and export them to Japan, is required to be accredited by the MHLW as an “Accredited Foreign Manufacturers”.
The accreditation is granted for each manufacturing establishment according to the category specified by the Enforcement Regulations.
A representative organization, who has a MAH license, can make and submit an accreditation application on the manufacturer’s behalf.
FMA requirements
(1) Renewal of FMA
Unless an “Accredited Foreign Manufacturer” renews their accreditation within its 5-year effective period, their accreditation becomes null and void.
(2) Notification on changes
When an “Accredited Foreign Manufacturer” makes changes in the following matters, they must notify the fact to the authority within 30 days.
- Name or address of the person responsible for the manufacturing establishment
- Name of the executives responsible for the services.
- Name of the manufacturing establishment.
- Major part of buildings and facilities of the manufacturing establishment.
- Category and accreditation number, when a foreign manufacturer obtains additional accreditations for another category, or discontinues operation of their accredited manufacturing establishment.
The documents published by PMDA
Further details pertaining to FMA are published by PMDA as below.
*Explanation of Application for Accreditation of Foreign Manufacturers
*Category of Accreditation of Foreign Manufacturers
Japan MDC acts as your Representative
JMDC FMA Maintenance Services:
JMDC acts regarding FMA maitenance as the representative for overseas manufacturer. JMDC make closed communications with MHLW/PMDA and MAH companies in Japan on behalf of the Sterilization manufacturer.
JMDC provide FMA support services as follows.
- Support for obtaining accreditation.
- Management of accreditation maintenance.
- Consultation of necessity of accreditation renewal, notifications on changes.
- Handling of accreditation maintenance.
- Preparation and submission of required documents.
- Communications with authorities and distributors in Japan.
Don't hesitate to contact us concerning any questions which may arise.
