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  • 1.  Language requirements for labeling

    This message was posted by a user wishing to remain anonymous
    Posted 18-Nov-2021 17:02
    This message was posted by a user wishing to remain anonymous

    Hi,

    Is anyone aware of a source (ISO doc, etc...) with all countries language requirements for labeling of medical devices?  

    Thanks,

    Note: No problem locating language requirements for the EU, US and Canada and a few other large markets


  • 2.  RE: Language requirements for labeling

    Posted 19-Nov-2021 04:37
    Hello Anon,

    I am not sure you will find a single source with all country language requirements for labelling.  In most cases it is expected the local language is used, though there may be some exceptions for professional use devices in certain countries.  I know there are various white papers, country requirement summaries, and related information for translation needs.  It might be helpful to contact a translation companies as sure they have this type of information consolidated together or at least would be able to indicate what is needed per country.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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