Regulatory Open Forum

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  • 1.  Repackager & COO

    Posted 16 days ago

    Hi RAPS community,

    I have a question regarding the COO when we import to the US from Canada.

    We are the repackager for a device, will the device's COO change to Canada because we are the final party of this device? My own judgment from the US regulation would prefer to determine the COO to Canada but I would like to have a confirm from the community.

    Thank you in advance.



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    Lulu (Silu) Zhang
    PRRC/Management Representative
    Head of Quality and Regulatory Affairs
    Canada
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  • 2.  RE: Repackager & COO

    Posted 15 days ago

    Hi Lulu

    Unless the repackaging causes a tarriff change, Canada probably does not become the COO. The COO is more likely wherever the last "substantial transformation" was done.

    https://www.ecfr.gov/current/title-19/chapter-I/part-134



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    Anne LeBlanc
    United States
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  • 3.  RE: Repackager & COO

    Posted 15 days ago

    Silu,

    Also would say probably not, because re-packaging of a product does not change the product (transformation) or add further value to the finished product.  In the United States, the country of origin is often based on the percentage of materials which are contained in the finished product and relationship of making the product (transformation).  As an example, an automobile has hundreds/thousands of parts from around the world but if the entire engine, chassis, interior is made in Germany, then most likely Country of Origin (COO) would be Germany.  Some companies try to "play" with these interpretations because it is more desirable to have COO as one country over another.  Including doing things like assembly or re-packaging in a country to claim COO - you would want to make sure the requirements are being understood.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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