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  • 1.  New Term Application For GMDN

    Posted 13-May-2013 04:29
    Does anyone have the experience to apply for a new term for GMDN? What kind of documents should be prepared and how long to get the GMDN code? Thanks a lot.

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    Ye Pan
    Johnson & Johnson Medical (shanghai) Ltd.
    Shanghai
    China
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  • 2.  RE:New Term Application For GMDN

    Posted 14-May-2013 01:33
    I have used MDSS for retrieving GMDN codes. I know it looks like they only help with the search, but I think they can help you with the application or provice more information on it.

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    Florian Tolkmitt
    sfm medical devices GmbH
    Germany
    florian.tolkmitt@sfm.de
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    Original Message


  • 3.  RE:New Term Application For GMDN

    Posted 14-May-2013 03:21
    Ye Pan

    In a previous role in the company I applied for a new GMDN Term in 2005, and checking on the paperwork, it seems to be completed in two weeks.

    We only supplied the application form (Form B v4 at this time) and the fee €200 as we were members at the time.

    We did not supply any other supporting data at the time

    yours

    Simon

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    Simon Leppard  PhD
    Director Regulatory Affairs
    BTG PLC
    Farnham, Surrey
    United Kingdom
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    Original Message


  • 4.  RE:New Term Application For GMDN

    Posted 14-May-2013 09:25
    The GMDN website will have the application form for you to complete. They will want basic information about your product including intended use, target audience, the context in which it will be used, the technology that is used, and constituent information among others and they use this to come up with the most generic code that they can so that it is not product specific. You will also need to supply your IFU. There is a nominal fee to have the GMDN Agency issue a new code and it usually takes about 3 weeks for it to be completed.

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    Rachael Williamson
    Regulatory Affairs Manager
    Alere San Diego, Inc.
    San Diego CA
    United States
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    Original Message


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