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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? 


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    Cathy S
    Manager
    Bridgewater NJ
    United States
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  • 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".

    Application:
    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

    http://www.pmda.go.jp/

    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


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    Amit Jain
    United States
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