Medical Devices
The importation of medical devices into the United States is subject to a complex regulatory framework involving both the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP). Tariff classification of medical devices under the Harmonized Tariff Schedule can be particularly challenging, as product characteristics, intended use, and technological components all factor into proper classification. Duties, trade remedy measures, and country-of-origin requirements add further layers of compliance. NE&J advises manufacturers, distributors, and importers on the customs and trade law dimensions of bringing medical devices to market, including tariff classification disputes, duty optimization strategies, FDA import procedures, and the impact of trade policy developments on the medical device supply chain.