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  • 1.  Return Product to US

    This message was posted by a user wishing to remain anonymous
    Posted 23-Nov-2020 16:34
    This message was posted by a user wishing to remain anonymous

    Dear community,

    One of our distributors in South America is retuning one of our medical devices. The device is manufactured in the US and approved by FDA. It seems that we will need to notify Customs Border Protection of the entry of the device, but we are not sure if this is applicable to returning US products. 
    Is anyone here familiar with the return process that could provide us some advice on the steps to follow?
    Thank you!


  • 2.  RE: Return Product to US

    Posted 25-Nov-2020 14:54
    Hi,

    From my experience with a previous company (~6 yeas ago), a return from a foreign country may be checked by a FDA customs agent.  The agent would call the US company that the device was being returned to and ask for their establishment registration number, the clearance number for the device, the listing number for the device and sometimes the product code.  Once the customs agent verified that information, they would release the product to come into the U.S.   I don't believe we notified them prior to the return.  Adding that FDA clearance information to the paperwork shipped with the returned device may facilitate smooth entry.  I have not dealt with this recently.  

    Kind Regards,

    ------------------------------
    Alyssa Thomas RAC
    Principal Consultant
    Beaverton OR
    United States
    ------------------------------

    Original Message


  • 3.  RE: Return Product to US

    Posted 30-Nov-2020 08:37
    Good Morning....

    Our freight broker/forwarder handles our returns.  We have never had an issue with returned medical devices from many different countries.

    Best regards,

    ------------------------------
    D Michelle Williams
    VP - Operations
    United States
    ------------------------------

    Original Message


  • 4.  RE: Return Product to US

    This message was posted by a user wishing to remain anonymous
    Posted 02-Dec-2020 17:06
    This message was posted by a user wishing to remain anonymous

    We manufacture devices within the US, and distribute them worldwide.  We frequently have products shipped back to the US, for a variety of reasons.  We have never notified US CBP prior to their return.  Occasionally, our freight forwarded will contact us and request further information on behalf of CBP.  As Alyssa mentions below, we are asked for the establishment registration number, the clearance number for the device, the listing number for the device and sometimes the product code.   Once that information is provided, the product is released and all goes quite smoothly.
    Original Message


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