Medical Products: Source Globally. Import Right.
The world’s best medical products come from Germany, China, India, Japan, South Korea, and Southeast Asia. Getting them from factory to US healthcare facility requires more than a freight booking. It requires customs clearance by someone who understands FDA regulations, carrier selection appropriate for fragile or cold-sensitive cargo, and supplier documentation management designed to prevent holds at the US border — not respond to them.
Licensed U.S. Customs House Broker · IATA-Compliant · Cold Chain Certified · Global Network
Our Capabilities
Global Sourcing
Supplier Vetting
Quality Docs
Import Clearance
Inventory
Compliance
Medical Product Categories We Import
Medical Devices — All FDA classification categories. Class I consumables, Class II diagnostic and therapeutic devices, Class III implantables, and IVD test kits. We verify FDA establishment registration and device listing before the shipment moves — not at the port of entry.
Pharmaceutical Raw Materials & Finished Dose — API from India and China. Finished pharmaceutical products from Europe. FDA Prior Notice filing, cGMP compliance documentation, and accurate entry classification for Chapter 30 products on every shipment.
Personal Protective Equipment — Nitrile exam gloves from Malaysia and Thailand. N95 and KN95 respirators, surgical masks, gowns, and face shields from China and South Korea. Quality documentation management and FDA EUA compliance where applicable.
Source Countries
China — Devices, PPE, diagnostics, hospital equipment. Full FDA import management, Section 301 tariff classification, import alert screening. China medical import →
India — Generic pharmaceuticals, API, biosimilars. Import Alert 66-40 screening, cGMP compliance review, cold chain on the India–US lane. India pharma import →
Germany — World-leading medtech: Siemens Healthineers, B. Braun, Dräger, and hundreds of Mittelstand manufacturers. CE to FDA transition support, high-value equipment expertise, CEIV Pharma cold chain from FRA. Germany device import →
Import Compliance: What We Handle
Every US medical product import involves multiple agencies. We manage all of them.
FDA — Device registration and listing verification (21 CFR 807). Prior Notice for pharmaceutical imports. Import alert screening on every product and manufacturer. Exam coordination when FDA selects your shipment.
CBP — Accurate 10-digit HTS classification. ISF filing for ocean shipments. Formal entry summary. Section 301 tariff assessment and exclusion identification for Chinese-origin goods. ADD/CVD screening.
Our Process
Pre-shipment review — FDA registration check, import alert screening, HTS classification, compliance issue identification. Before freight is booked.
Supplier documentation guidance — Tailored checklist for your overseas supplier: invoice format, certificates, FDA registration reference, origin declarations, product-specific documents.
Freight booking — Air or ocean, cold chain if required, appropriate carrier for your cargo type.
Ready to Ship Medical Cargo with Confidence?
Get a quote from MedShip — specialist medical freight backed by a licensed U.S. Customs House Broker.