Medical Device Customs Clearance and FDA Compliance
Licensed customs broker for medical devices, healthcare equipment, and diagnostic instruments.
What You Need to Import Medical Devices to the USA
Importing medical devices requires compliance with regulations from the FDA and CBP. Here’s what you need to know before your shipment arrives.
Required Documents
Key Agencies
Duty Considerations
Common Challenges for Medical Devices Importers
FDA 510(k) Requirements
Class II medical devices require FDA 510(k) clearance before importation. Importing without clearance results in seizure and potential criminal penalties.
Device Establishment Registration
All foreign manufacturers and importers of medical devices must register with the FDA annually. Shipments from unregistered establishments are detained automatically.
CBP and FDA Coordination
FDA and CBP work together to screen medical device imports. Our team ensures all registration, 510(k), and labeling requirements are in order before arrival.
How FreightClear Handles Medical Devices Imports
- Upload Your Documents — Share your commercial invoice, bill of lading, or packing list. Our AI extracts everything instantly.
- We Classify and File — FreightClear classifies your HTS codes, files your ISF, and prepares your CBP entry.
- Your Goods Are Released — Our licensed US customs broker manages CBP release and arranges last-mile delivery.
Frequently Asked Questions
What is a 510(k) and do I need one?
A 510(k) is FDA’s premarket notification for Class II medical devices. Most Class II devices require 510(k) clearance before import. Class I devices are generally exempt; Class III require PMA approval.
Does every medical device shipment get FDA-inspected?
Not every shipment is physically inspected, but FDA reviews entry documentation for all medical device shipments. Missing registration or 510(k) documentation triggers examination.
What is the DUNS number requirement for medical devices?
The FDA requires a DUNS number for device establishment registration. Your foreign manufacturer must have an active DUNS number registered with the FDA.
Are medical devices duty-free when imported to the USA?
Most devices under HTS Chapter 90 are duty-free. However, some are classified elsewhere and carry duties. Precise HTS classification is essential.
Ready to Import Medical Devices to the USA?
FreightClear is a licensed US customs broker. We make imports simple — from document upload to delivery.
Licensed U.S. Customs Broker · WCA Founding Member · 38 Years of Expertise