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  • 1.  Foreign Manufacture Accreditation in Japan

    Posted 06-Sep-2013 08:32
    I am seeking information on obtaining a FMA (Foreign Manufacturer Accreditation) for a testing facility as per Japan regulations.  This has also been referred as an OMC (Overseas Manufacture Certification) certificate.  I understand them to be one in the same.  I was informed that this information is on the PMDA website.  Can anyone give some direction as to where this information may be located? 

    Cathy S
    Bridgewater NJ
    United States

  • 2.  RE:Foreign Manufacture Accreditation in Japan

    Posted 06-Sep-2013 15:19
    Hello Cathy,

    Yes, that's correct any foreign manufacturer intending to manufacture/export them to japan is required to be accredited by minister of health Japan as "FMA".

    1. Submit "application to accreditation" form 18 to minister and from 16 to chief executive PMDA, Administration division II, Office of review Administration of PMDA.
    2. Applicant is a corporation, names of the corporation and their CEO.
    3. "Applicant" is to be responsible to renew their accreditation every 5 years.
    4. Examination Fees for the accreditation differ between on-site and document examinations.
    5. The period can be estimated to be about 5 months
    Documents required:
    • Medical Certificate indicates whether or not an "Applicant" has mental disorders or is addicted to narcotics, cannabis, opium or stimulant drugs".
    • A medical certificate and the other required documents for accreditation can be written in any language, but their Japanese translations are required.
    • "A curriculum vitae of the person who is responsible to the manufacturing establishment"
    • List of products" to be manufactured for exporting to Japan and "Documents on manufacturing process".
    • "A document on buildings and facilities of a manufacturing establishment".
    • "When radiopharmaceuticals are included, a document on the type of the radiopharmaceuticals and outlines of facilities for handling such radiopharmaceuticals".
    • When a system for marketing license, a copy of the license certificate issued by governmental organizations etc. of the country under such system".
    Contact Info:

    Advising Division/Office with respect to Application for Accreditations
    1.   General questions on applications and Inquiries about review status Administration Division II, Office of Review Administration FAX: +81-3-3506-9442
    2.   Examination of buildings and facilities of manufacturing establishment to be accredited
    GMP Inspection Division, Office of Compliance and Standards (Pharmaceuticals excluding In vitro diagnostics and quasi-drugs) FAX: +81-3-3506-9465
    Medical Device Quality System Inspection Division, Office of Compliance and Standards (Medical devices an In vitro diagnostics) FAX: +81-3-3506-9465

    For more info: go to

    Then turn language to english (Top-right corner of website)
     Home: scroll down
     Services of PMDA (middle-Bottom of website) green box
     Drug and Medical Device Reviews
    Regulations and Procedures (on Left side, 2 bold heading, below package insert)
     Accreditation of Foreign Manufacturers(right box, under second bold heading).

    Best Regards

    Amit Jain
    United States