Medical devices, including electromedical instruments such as ultrasound systems, ECG monitors, and therapeutic devices, must be cleared or approved by the FDA before importation. The applicable pathway (510(k) substantial equivalence, De Novo, or PMA) depends on the device's risk classification. CBP coordinates with FDA at the port of entry, and shipments of unapproved devices may be detained or refused admission. Importers should confirm FDA registration and device listing status before the first shipment.

Under Chapter 90 of the HTS, instruments are classified by their primary function and the sector they serve — optical instruments, surveying instruments, medical instruments, and industrial process control instruments each occupy distinct headings. An instrument that could serve multiple purposes (e.g., a pressure sensor used in both medical and industrial applications) must be classified by its principal use as imported, supported by documentation such as the manufacturer's product description and the importer's purchase order specifying the intended application.