Regulatory Open Forum

 View Only
  • 1.  Product Label Translations Requirements

    Posted 21-Apr-2018 08:34

    Hello All. I am working with a client to streamline their labeling process and encountered one challenging question regarding translation requirements for product name and description. Do product labels require translation of BOTH product name AND product description? I am trying to avoid translating product description on the product labels.

     

    I checked MDD and EN1041 and was not been able to find any regulations specific to product name and product description translations. The MDD has just the one general section that mentions translation but doesn't specify requirements for product name or description. However, I know that it's common practice that the product trade names (especially trademarked) do not get translated. If we assume the product name does not need to be translated, can we include the product description in the product name and avoid translation?  

     

    In summary, I would like to eliminate the need to translate the product description on the product labels by including it with the product name. Do you agree? Will I be breaking any regulations that you may be aware of?

     

    Looking forward to receiving your feedback!

     



    ------------------------------
    Al Saalabi
    President of Med Dev Global Solutions
    Minneapolis MN
    United States
    ------------------------------


  • 2.  RE: Product Label Translations Requirements

    This message was posted by a user wishing to remain anonymous
    Posted 23-Apr-2018 16:50
    This message was posted by a user wishing to remain anonymous

    Product description doesn't required to be on the label per regulations. Product Name requires to translate in certain countries like China, Russia per the country specific regulations.