Newly Released CBP HQ Rulings Oct. 7
The Customs Rulings Online Search System (CROSS) was updated on Oct. 7 with the following headquarters rulings (ruling revocations and modifications will be detailed elsewhere in a separate article as they are announced in the Customs Bulletin):
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H339462: U.S. Government Procurement; Title III, Trade Agreements Act of 1979 (19 U.S.C. 2511); Subpart B, Part 177, CBP Regulations; Country of Origin of IV Drips
| Country of Origin: In Scenarios One, Two, and Three, the last substantial transformation of the Biomedix Selec-3 Multiple Drop Intravenous Product occurs in the United States, while the country of origin in Scenarios Four and Five is Mexico. |
| Issue: What is the country of origin of the Biomedix Selec-3 Multiple Drop Intravenous Product for purposes of U.S. government procurement? |
| Item: Biomedix Selec-3 Multiple Drop Intravenous Product, imported by Wai Medical Technologies and its affiliate MedSource International. The Selec-3 IV Product is an intravenous set made with components from a variety of U.S. and non-U.S. components. The Selec-3 IV Product has a patented selectable drop chamber (SDC) that offers three drop settings. |
| Reason: Wai Medical requested that CBP issue a determination covering all five scenarios listed accordingly. Scenario 1: All of the Selec-3 IV Product components originate from the United States, are sterilized in the United States, and then are assembled in India prior to being re-imported, and fully assembled in the United States. Scenario 2: The SDC originates from the United States and is assembled into the SDC sub- assembly (including the roller clamp and spike) in the United States. The remaining components originate, are sterilized, and assembled in India. The final assembly takes place in India. Scenario 3: The SDC originates from the United States. The SDC sub-assembly takes place in India. Additionally, remaining components originate, are sterilized, and assembled in India. The final assembly takes place in India. Scenario 4: The SDC originates from Mexico and all components (including SDC) are sterilized and assembled in India. All of the Selec-3 IV Product components, except the SDC, originate and are sterilized in non-TAA eligible countries. The final assembly takes place in India. Scenario 5: The SDC components originate and are assembled into the SDC sub-assembly in Mexico. All other parts of the Selec-3 IV Product originate from China. Sterilization of the entire product occurs in China. The final assembly takes place in India. CBP finds that in the case at hand, the SDC is patent-protected, and it performs the most critical function of the Selec-3 IV product, i.e., regulating the drip rate of the fluid being administered to the patient. Importantly, the SDC sub-assembly consisting of the SDC plus the roller clamp and the spike represents the single most significant portion of the cost of materials of the Selec-3 IV Product. Here, the SDC imparts the essential character of the Selec-3 IV product because it serves the product’s most important function. Additionally, sterilization only represents a small portion of the total cost of production of the subject merchandise. Consistent with HQ H035441, CBP finds that the sterilization process should not result in substantial transformation. |
| Ruling Date: May 13, 2025 |