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  • 1.  CUSTOMS, Regulatory or Labeling issue? US & Canada

    Posted 18-Oct-2017 18:58
    Hi Regulatory Colleagues,

    It has been a while! We have an issue here where we are trying to import condoms into the facility here in the US to be shipped to Canada.  The condoms are coming in from the Croatian distributor, to the US distributor, and then shipped off to Canada.  The following is a breakdown of the scenario and the issue we are facing.  

    Manufacturer info: When we registered the condoms for Canada, the manufacturer information is listed as the manufacturer in China (Private Label Manufacturer).

    The US registration, lists the actual manufacturer on the label.

     

    Intended Use info: 

    In Canada, the intended use is  Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections (STIs).

    in USA, the intended use is xxx condom is a natural rubber latex condom used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). (This intended use is required by USA FDA, we proposed the same one as the Canada, but it was rejected and unfortunately at the time, we had finalized the EU (CE) and Canada's intended use in the certificate, so EU (CE) and Canada cannot be changed).

     

    So, will there be a problem if we move condoms packaged in Croatia for Canada to our US based distributor for shipment to Canada from Croatian warehouse?


    Will CUSTOMS even check this during importation? Does it really matter? Should the labeling be changed here once the condoms het to the US?


    Please advise as to what our best options are as this is a very tricky situation. :)


    Thanks so much!


    Laura 



  • 2.  RE: CUSTOMS, Regulatory or Labeling issue? US & Canada

    Posted 19-Oct-2017 16:58
    Somewhere there is a guidance on "import for export" that you may be able to leverage. However, if memory serves, it really deals with components, not finished devices, so it probably won't fully apply. Even so, if you really want to do this, I'd make sure you go through it and address every principle that applies, and document how you do so.

    Yes, US Customs will check. Probably not every time, but often enough. And this product space tends to be one they have significant concerns around over the years, so you can be sure they will ask a lot of questions. You will need to convince them you have the right to trans-ship and the controls to ensure none get diverted into US market.

    g-

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    Ginger Glaser RAC
    Vice-President, Engineering
    MN
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  • 3.  RE: CUSTOMS, Regulatory or Labeling issue? US & Canada

    This message was posted by a user wishing to remain anonymous
    Posted 23-Oct-2017 11:24
    This message was posted by a user wishing to remain anonymous

    Here is the link to FDA's IfE program
    https://www.fda.gov/ForIndustry/ImportProgram/ImportBasics/ucm432248.htm


  • 4.  RE: CUSTOMS, Regulatory or Labeling issue? US & Canada

    Posted 24-Oct-2017 09:45
    Customs and USFDA or if you import to Canada then Health Canada will look at the device manufacturer's registration and device registration and listing. As long all of those are there and match you should be good.

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    Artur Shchukin
    New York NY
    United States
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  • 5.  RE: CUSTOMS, Regulatory or Labeling issue? US & Canada

    Posted 24-Oct-2017 11:26
    Thank you all for such great advice.  As always, I can always count on my seasoned colleagues to help with complex issues as these, issues totally out of my realm of expertise.


    Thanks again,
    Laura HoShue

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    Laura HoShue
    Regulatory Compliance Specialist
    Las Vegas, Nevada
    USA
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