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  • 1.  Medical Device Registration Chile

    Posted 15-Jan-2015 09:11
    Dear All,

    currently we are searching for an answer to the following question - is anyone familiar with the legal requirements in Chile of plasters containing a silver wound pad?

    In fact, no registration is required for this type of medical device (wound plaster) at all - nevertheless we are not sure whether any other type regulation e.g. any pharmaceutical regulation needs to be applied.

    Thanks & Regards,

    -------------------------------------------
    Florian Grimm
    Expert Quality & Regulatory Affairs
    Beiersdorf AG
    Hamburg
    Germany
    -------------------------------------------


  • 2.  RE: Medical Device Registration Chile

    Posted 16-Jan-2015 13:58
      |   view attached
    Dear Florian,

    You are correct, in Chile, at this point, medical device registration is optional. However, you need to have local representation ("importador" or "agente de aduana") which will be responsible for import process, storage and distribtuion of your product in Chile.

    For your information, I am attaching the official instructions (my apologies, but the document is in Spanish). If you need further assistance, I will be happy to help you.

    Warmest regards,

    -------------------------------------------
    Marcela Saad RAC
    President & Senior Consultant
    MarcM Consulting Canada
    +1 519-579-0821
    Kitchener ON
    Canada
    -------------------------------------------


    Attachment(s)

    pdf
    medical devices instructivo.pdf   264 KB 1 version
    Original Message