Regulatory Open Forum

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  • 1.  Country of Origin

    This message was posted by a user wishing to remain anonymous
    Posted 31-May-2023 08:42
    This message was posted by a user wishing to remain anonymous

    Hello. If a device is designed in the US (DA located in US), manufactured in China, then shipped to US for final packaging to be completed, would the CoO be US? If that same device is designed in the US, manufactured and packaged in China, and shipped to US for distribution would the CoA be China? Regarding labeling: what needs to be included on the device labeling by the manufacturer and/or distributor? TIA

  • 2.  RE: Country of Origin

    Posted 31-May-2023 09:33

    Hello Anon

    If the device is being distributed in the US, it is not required to state the country of origin. If you choose to mention a country of origin, then the FTC rules apply, e.g. determining and documenting percentages of value added in each country.

    The basic device labeling rules require disclosure of a responsible company, e.g. manufacturer or distributor.

    Anne LeBlanc
    United States

  • 3.  RE: Country of Origin

    Posted 31-May-2023 12:13

    When FDA regulated products are imported into the United States, information is required to comply with United States Customs and Border Protection (CBP) and the Food and Drug Administration (FDA) requirements.  

    As per 21 CFR 801.1 FDA requires that the label of a device shall contain the name and place of business of manufacturer, packer, or distributor including the street address, city, state, and zip code.

    CBP (19 CFR 134) on the other hand considers the country of origin to be the last country where processing resulted in a substantial transformation which in other words mean that the country of origin is where the last processing occurred to create a product with a new name, character or use. Given the basic information for your case it seems likely that China would be the COO but it entirely depends on the process. 

    FTC (Federal trade commission) rules would come into play when you make "Made in USA" or other similar qualified claims. COO determination is complex and confusing but I hope this helps.

    Mehul Govani RAC
    Regulatory Affairs Manager
    Bellerose NY
    United States

  • 4.  RE: Country of Origin

    Posted 02-Jun-2023 12:20

    Hello Anon,

    What Anne provided - it can be the last country where activities occurred, but also depends on the percent of components/value which are put in the product as well.  The FTC gets a little iffy on companies where all the parts are made outside the US and then only packaged in the US to say "Made in USA" when really it is not.  There are even companies outside the US which will ship all components or finished goods to the US to be packaged there to say "Made in USA" and then exported back to the originating country.  I know, weird, but it does happen.  Indeed have to be careful and have full understanding of how you apply country of origin.

    In the United States, the Manufacturer is identified on the device labelling as "Manufactured by:" and if a distributor or other company is used, then states "Manufactured for:"  The full information of the Manufacturer and any original manufacturer/contract manufacturer would then be located in the FURLS database.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs