Tariff and customs classification

Tariff and customs classification for Healthcare & Life Sciences products is one of the more technically unforgiving compliance areas in international trade, where a single Harmonized System code misapplication on medical devices or pharmaceutical inputs can trigger duties, seizures, or import holds. The U.S. Customs and Border Protection and the U.S. Food and Drug Administration share overlapping jurisdiction at the border, and in Europe, national customs authorities operating under European Union Combined Nomenclature rules have tightened scrutiny on combination products and IVD reagents since the EU Medical Device Regulation fully took effect. Classification disputes are not theoretical: binding ruling requests, prior disclosure filings, and CBP audit activity have all increased in the post-tariff-action environment covering Chinese-origin components.