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  • 1.  International Device Registration fees

    Posted 07-Feb-2013 07:56
    I am looking for medical device registration fees for France and Portugal.  Can anyone suggest a link or reference for this information?  Also, is it true that Italy no longer requires a fee to list in the Italian database?

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    Christine Nichols RAC
    Consultant
    Regulatory Consulting Services
    MA
    United States
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  • 2.  RE:International Device Registration fees

    Posted 22-Feb-2013 10:24
    Dear Christine,

    Here is a partial answer for your question.  I checked INFARMED, the sanitary agency that oversees the registration of medical devices in Portugal, and the fee charged for registration of a MD in Portugal is 0.4% of total sale. This information can be found in the Decrete-Law Number 312/2002, of December 20.  The link for this information is: http://www.infarmed.pt/portal/page/portal/INFARMED/TAXAS

    Valeria

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    Valeria Sena-Weltin RAC
    New Market MD
    United States
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