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Medical Devices Substantially Transformed by Assembly in Mexico, CBP Says

Thursday, December 06, 2018
Sandler, Travis & Rosenberg Trade Report

U.S. Customs and Border Protection has issued a final determination concerning the country of origin of a medical device that may be offered to the U.S. government under an undesignated government procurement contract. Any party-at-interest may seek judicial review of this determination by Jan. 2. 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.

According to CBP, the product at issue is a brace that covers the ankle and foot and is designed to treat certain medical conditions. It is composed of a semi-rigid shell and an adjustable aircell located under the foot arch. The components of the brace are sourced from four different countries and assembled into the finished product in Mexico.

In ruling HQ H299701 CBP concludes that the manufacturing operations conducted in Mexico cause the components to lose their individual identities and become part of the finished product. CBP also finds that the aircell, which is produced in Mexico using parts from other countries, imparts the essence of the finished brace. As a result, CBP determines that Mexico is the country of origin of the brace for purposes of government procurement.

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