Overseas Import Services for FDA-Approved Medical Equipment
Reliable customs clearance and overseas import solutions for FDA-compliant medical devices.
Have you ever had your shipment “released” by the FDA, only to wait days or even weeks for final clearance? Importing medical equipment from overseas doesn’t have to be complicated or frustrating. Universal Diagnostic Solutions, Inc. (UDS) removes the guesswork and manages the entire import process on your behalf.
We clear cargo through LAX or Long Beach ports and can deliver it directly to our warehouse for pickup—or to any U.S. destination port you prefer. From customs clearance to final logistics, we handle everything from start to finish while coordinating seamlessly with your trucking company.
FDA-Compliant Medical Equipment Import & Customs Clearance
All medical equipment entering the United States must comply with U.S. Customs and Border Protection regulations, FDA requirements, tariff classifications, and duty assessments. Depending on the shipment, inspections, surety bonds, permits, or special entry standards may be required.
Our licensed import professionals bring years of experience navigating complex customs and FDA regulations. We ensure your FDA-approved medical equipment moves efficiently through every stage of the import process—avoiding costly delays.
- U.S. Customs clearance
- Door-to-door or port-to-port forwarding
- Tariff classification & duty management
- Bills of lading preparation
- Global agent coordination
- Rapid issue resolution
If an issue occurs, we already know how to resolve it.
Medical Equipment Import Compliance & FDA 510(k) Requirements
Medical equipment imported into the United States must have an FDA 510(k) premarket notification for legal installation and operation. Universal Diagnostic Solutions, Inc. (UDS) can assist with compliance guidance and In-Bond entries when required.