Regulatory Open Forum

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  • 1.  Shipping Carton Sanity Check

    Posted 09-Aug-2016 23:53
    Edited by Tina O'Brien 10-Aug-2016 00:00

    Is anyone aware of any regulation that requires labeling information to be printed directly on the outer cardboard shipping container/box and may not appear anywhere else (e.g. on a label affixed to the box)?  

    We're considering going with plain boxes (with regulatory-complaint labels affixed) for international shipping and want to confirm that we aren't required to print anything directly on the box to get through customs.

    I've checked Tarius for all of the countries and don't see a thing on this topic, so I suspect it's not an issue. 

    Thanks in advance for any information to the contrary!

    Tina

    ------------------------------
    Tina O'Brien RAC, MS
    Sr. Regulatory Affairs Specialist
    Fisher & Paykel Healthcare
    Auckland
    New Zealand
    ------------------------------



  • 2.  RE: Shipping Carton Sanity Check

    Posted 10-Aug-2016 03:50

    As far as I have seen, a shipping label is a shipping label.  It is not covered in the medical device regulations.  It is for shipping.

    If however the shipping container is the actual container used and needs a label - then you must have all the applicable fields.

    ------------------------------
    Sharon Goldfarb-Albak
    Vice President, Regulatory and Clinical Affairs
    GI View Ltd.
    Ramat Gan
    Israel



  • 3.  RE: Shipping Carton Sanity Check

    Posted 10-Aug-2016 09:35

    Hi, Tina,

     

    Our shipping boxes are plain with corporate logos only and all of our product labels are printed separately and affixed to these plain boxes, so I cannot imagine that there are any regulatory requirements for direct printing of regulatory information on the package/box itself.

     

    Hope that helps!

     

    Sue

     

    Sue Weinacht
    Specialist II, Regulatory Affairs
    Regulatory Operations


    St. Jude Medical
    One St. Jude Medical Drive
    St. Paul, MN 55117
    Tel +16517563154
    Fax +17633832771
    sweinacht@sjm.com

    sjm.com

     


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  • 4.  RE: Shipping Carton Sanity Check

    Posted 10-Aug-2016 12:49
    Tina,

    It is worth reading the following for awareness purposes.

    21 CFR Part 1, Subpart B (sections 1.20 through 1.24)

    David