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  • 1.  manufacturer name translation (language use)

    Posted 01-Dec-2020 10:28
    Dear all,
    please I need your advise on one point related to the language used for the manufacturer name.
    generally the name is in English but like in Canada the name is in French and also in our ISO 13485 the manufacturer name is in French.
    Could use both names in English and English for all our documentation?
    Do we have a restriction or should we proceed by a formal process to get a legal and specific name in English or French?

    Thank you in advance for your reply.

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    Nadine Adia
    Quebec QC
    Canada
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  • 2.  RE: manufacturer name translation (language use)

    Posted 14-Dec-2020 21:15
    Hi Nadine,

    I am not sure if I understand your questions exactly.  I will try to answer and see if other in the RegEx community can provide input.

    In the US the name of the company would need to be in English.  See 21 CFR 801 for medical device labeling requirements in the US.  I don't remember the label requirements in Canada; I assume French is acceptable in some provinces, or English and French.  The specific regulations associated with Canadian labeling would need to be reviewed.  

    The manufacturer's name should be the official name used for the company registration in the specific country were product is sold.  If the manufacturer's name includes a trademarked logo or something, there are trademark requirement that are specific to each country.

    I hope this helps or someone replies to provide additional insight.  

    Kind regards,

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    Alyssa Thomas RAC
    Principal Consultant
    Beaverton OR
    United States
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    Original Message


  • 3.  RE: manufacturer name translation (language use)

    Posted 06-Jan-2021 12:48
    Is there a specific document you have in mind when asking this question? For example, if you're looking at the CMC/Module 3 sections and the establishment information required on the application form, then I would use whatever company name was included in the establishment registration for the US. If you're more concerned about what is put on the labeling documents, then in the US I would generally default to English if you already have a legally defined English name, but if you don't, I'm not sure that it would really matter, but that's not my area of expertise. I would think that the most important factor be that it's a legally defined name.

    If you have a more specific example, it might help to share it to get a more precise answer.

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    Rachel Thornton
    Associate Director
    Smyrna GA
    United States
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    Original Message


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