Regulatory Open Forum

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  • 1.  Medical Device Labeling Mozambique

    Posted 23-May-2023 05:05

    Hey Guys,
    I am tasked with a device renewal in Mozambique.
    In the past, they always accepted labels in English, but this time they (i.e. the distributor who handles the registration) ask for labels in Portugese. Does anyone know whether there was a change in the legislation?

    Thank you for your help!
    Best,
    Britta



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    Britta Cyron
    Regulatory Affairs Manager
    Altsätten
    Switzerland
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  • 2.  RE: Medical Device Labeling Mozambique

    This message was posted by a user wishing to remain anonymous
    Posted 20-Jun-2023 09:12
    This message was posted by a user wishing to remain anonymous

    Hi Britta

    I don't see any new laws or regulations posted:  https://www.misau.gov.mz/index.php/leis

    It could be now considered best practice to label for the urban population's most shared language. Or maybe a customer preference.


    Original Message


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