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Brazil - Country of Origin approval required for IVDs?

  • 1.  Brazil - Country of Origin approval required for IVDs?

    This message was posted by a user wishing to remain anonymous
    Posted 11-Oct-2021 10:47
    This message was posted by a user wishing to remain anonymous

    Dear colleagues,

    Is country of origin approval required for registration of IVDs in Brazil? 

    The regulation for medical devices (RDC 185/2001, Part 3, item 5(d)) states that proof of registration in the country of origin is required for registration of product families in Brazil. However, this requirement is not found in the regulation for IVDs (RDC 36/2015).

    Thank you.


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