CBP and FDA require that the importing establishment and the foreign manufacturer be registered with FDA, and that the device be listed. Depending on device class, a 510(k) clearance number or PMA approval may need to be on file. FDA may detain shipments for examination if prior notice or registration requirements are not met.

Many medical equipment and supply HTS subheadings covering China-origin goods are subject to Section 301 tariffs, though some medical device lines received exclusions during and after the COVID-19 pandemic. Importers should verify the current status of any applicable exclusion for their specific HTS subheading before entry.