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CBP Determines Country of Origin of Wound Therapy System

Tuesday, July 07, 2015
Sandler, Travis & Rosenberg Trade Report

U.S. Customs and Border Protection has issued a final determination (HQ H259473) concerning the country of origin of a wound therapy system that may be offered to the U.S. government under an undesignated government procurement contract. This determination was issued June 30 and any party-at-interest may seek judicial review of it by Aug. 7. CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. government.

The product at issue is a sterile, single-use, complete negative pressure wound therapy system consisting of a pump, two dressings with attached long tube assemblies, and retention strips. Most of the pump’s components are made in China, except for a lightweight pipe, valve and connector made in the U.S., and the batteries. In the United Kingdom the pump will be flash programmed with U.S.-origin firmware and the final assembly of the pump will take place. The dressings are manufactured in the U.K. with materials of U.K. and Canadian origin. The dressing is connected to a long tube assembly also manufactured in the U.K. from U.K.-origin materials. When imported into the U.S. the pump and the dressings are not assembled together and must be connected by the user after the dressing is secured to the patient.

CBP concludes that the considering the system’s use as a single medical instrument, the origin of the dressings, and the flash programming and final assembly of the pump that will be performed in the U.K. and change the pump into a specialized pump that can only be used with its respective dressings, the country of origin of the system will be the United Kingdom for purposes of U.S. government procurement.

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