Importing Medical Devices to the US: Complete HTS Classification, FDA Requirements & Duty Guide 2026

Medical Devices: The Most Regulated Import Category

Medical devices are unique among imports: they face BOTH customs clearance (CBP) AND FDA regulatory clearance. A shipment can be perfectly classified under HTS and still be detained because the FDA has not cleared the device. This dual jurisdiction — customs for tariffs, FDA for market access — makes medical device importing the most compliance-intensive category in US trade.

Key HTS Codes for Medical Devices

FDA + CBP: The Dual Clearance Requirement

Before a medical device clears CBP, it must have FDA clearance. The type of clearance depends on the device class: Class I (low risk, e.g., bandages) requires general controls and establishment registration. Class II (moderate risk, e.g., infusion pumps) requires 510(k) premarket notification. Class III (high risk, e.g., pacemakers) requires PMA (Premarket Approval). Importing a Class II or III device without the correct FDA clearance = CBP detention at the port, potential seizure, and FDA import alert on your company. Every importer of record must have an FDA establishment registration and device listing before the first shipment arrives.

Section 301 & Medical Device Exclusions

Many medical devices from China are subject to Section 301 List 3 tariffs (25% additional duty). However, USTR has granted product-specific exclusions for certain medical devices — particularly those related to COVID-19 response, diagnostic equipment, and PPE. These exclusions are periodically renewed and expire. Check the current USTR exclusion list before filing entry. Claiming an expired exclusion = underpayment of duties + potential penalty. For devices not covered by exclusions, USMCA sourcing (Mexico/Canada assembly) eliminates both MFN and Section 301 duties if the device meets the 75% RVC requirement.

Disclaimer: This guide is informational. Medical device imports require FDA regulatory clearance in addition to customs entry. Consult an FDA regulatory consultant and a licensed customs broker.