Regulated / Industry

Healthcare Ocean Freight Forwarder for Medical Device, Biologics, and Hospital Supply

FCL, reefer air, validated 2-8°C / CRT cold chain, and TSA-certified handlers paired with FDA Pre-Market / 510(k) admissibility checks and clinical trial logistics. Hospital-grade chain of custody on every shipment.

Common lanes

Lanes we run for healthcare

Singapore to Memphis in 20 days. Direct contracts on the corridors your cargo actually moves on.

20 days (ocean) / 2 days (air)
Singapore (SGSIN)
to
Memphis (USMEM)
Hospital supply charter
2 days (air)
Frankfurt (DEFRA)
to
Indianapolis (USIND)
Medical device cold chain
2 days (air)
Seoul (KRICN)
to
Chicago (USORD)
Diagnostic panels
3 days (air)
Shanghai (CNSHA)
to
Dallas (USDFW)
PPE and consumables
3 days (air)
Basel (CHBSL)
to
Raleigh (USRDU)
Biologic clinical trial
2 days (air)
Tokyo (JPTYO)
to
Boston (USBOS)
Implantable device + research
Services

Built for healthcare

Reefer air, TSA-certified, FDA Pre-Market / 510(k), clinical trial logistics, hospital chain of custody.

Reefer + CRT air freight

Validated 2-8°C, frozen, and CRT air shipments with chain-of-custody logs from manufacturer to patient receiving.

TSA-certified handling

Indirect Air Carrier (IAC) certified agents. Screening, secure facilities, and driver vetting for high-value medical cargo.

FDA Pre-Market & 510(k)

Device registration verification before import. 510(k), Pre-Market, and ANDA device admissibility checked at booking — not at port.

Clinical trial logistics

Investigational product shipments, cold-packed kit distribution, site-pharmacy coordination, and patient-direct home delivery.

Hospital-grade chain of custody

Temperature logs, seal verification, signature capture, and audit-ready documentation surfaced live in the Gateway dashboard.

Emergency air charter

Same-day air charter, named-flight options, and 24/7 ops desk for device implant emergencies and trial-day deliveries.

Product Sonar · PO management

Run your healthcare POs from one screen

Product Sonar tracks the lifecycle of every PO — search by SKU, see stock counts, trace shipment status, and check duty exposure live.

Product Sonar
Product Sonar — Search view of SKU lifecycle
  1. Search
    Find any SKU in seconds
    Search your full catalog by SKU, HS code, supplier, factory, or origin country. One bar, no spreadsheets.
  2. Stock
    Live stock counts per SKU
    How many you ordered, how many are on the water, how many landed. One number per SKU at a glance.
  3. Trace
    PO lifecycle, end to end
    Trace every PO from cut to delivery. Container, vessel, customs, FTZ, final-mile — every stage timestamped.
  4. Duties
    Live duty exposure
    MFN, Section 301, AD/CVD per SKU. See landed cost before the container leaves origin.
Hospital-grade discipline

Hospital-grade chain of custody — your patients are not waiting on a missing PDF

Most ocean and air forwarders treat medical device and biologic freight as another high-value cargo class. Temperature logs are produced after the fact, FDA admissibility is checked at port, and chain-of-custody signatures are scattered across email and spreadsheets.

Gateway runs hospital-grade discipline. Every reefer ships with IoT temperature, humidity, and door-event loggers streaming live to the Gateway dashboard. Every TSA-certified handler signature is captured. Every FDA 510(k) and Pre-Market admissibility check is run before the vessel sails or the flight takes off.

When QA pulls the audit, the records are clean. When a cardiac device needs to be implanted in 36 hours, the freight is on the table. When a clinical trial site needs investigational product on Monday, it lands Friday — not next week.

Integrations

Connect your stack — Gateway integrates

Plug Gateway into the systems your hospital, manufacturer, or trial sponsor already runs on. POs, lot codes, FDA filings, and shipment milestones stay in sync.

SAP logo
SAP
Two-way sync for POs, ASNs, ETAs, and customs. Built for SAP-native medical device manufacturers and pharma companies.
Oracle logo
Oracle
Two-way sync for purchase orders, shipment milestones, and landed cost. Built for complex hospital and CRO supply chains.
NetSuite logo
NetSuite
Two-way sync for inbound POs, vendor bills, and lot-level inventory. Mid-market device companies and diagnostic labs.
QuickBooks logo
QuickBooks
Gateway invoices land in your QuickBooks automatically. No manual entry for smaller distributors and surgical specialty groups.
EDI / API logo
EDI / API
EDI 850/856/810/214 plus REST API. Built for hospital GPO integrations (Premier, Vizient, HealthTrust) and 3PL warehouse systems.
Why Gateway

The difference on your freight

1

Hospital-grade, not marketing-grade

Every temperature reading logged, every driver vetted, every chain-of-custody signature archived.

2

FDA does not hold your patients

Pre-import admissibility checks catch registration and labeling issues before the vessel leaves origin.

3

Emergency is standard

Same-day air charter, named-flight options, and 24/7 ops desk for device and biologic emergencies.

FAQ

Common questions

What is a healthcare ocean freight forwarder?

A healthcare ocean freight forwarder books vessel and air space, maintains validated cold chain, and manages FDA-regulated customs filings (Pre-Market, 510(k), ANDA, biologic registration) for medical device, biologic, diagnostic, and hospital supply importers. Gateway is an NVOCC with TSA-certified handlers, IoT temperature monitoring, and 24/7 emergency air charter capacity.

Does Gateway handle TSA-compliant medical device shipments?

Yes. Gateway works through Indirect Air Carrier (IAC) certified agents with screening, secure facilities, and driver vetting for high-value medical cargo. TSA-compliant chain of custody is preserved from manufacturer pickup through final hospital, pharmacy, or trial-site delivery.

How does Gateway maintain cold chain for biologics and clinical trials?

Validated 2-8°C reefer, frozen, and controlled-room-temperature (CRT) containers ship with IoT data loggers reporting temperature, humidity, and door events live to the Gateway dashboard. Excursion alerts fire instantly. Clinical trial investigational product, cold-packed kits, and site-pharmacy distribution are coordinated by a dedicated trial logistics team.

Ready to move healthcare with Gateway?

Get a rate in 24 hours or talk to a healthcare specialist about your next shipment.