Written and maintained by CASRAI Editorial Board
Published · Last updated
On this page
A freight forwarder for medical devices arranges the movement of device shipments and prepares the paperwork around them. It does not replace the importer’s own duties to the US Food and Drug Administration (FDA). This page is for clinic, laboratory and distributor staff who need to know who does what, which questions to put to a forwarder, and which details on an import entry must match what FDA holds. It describes general roles and requirements; it is not legal or medical advice.
What a freight forwarder does
The US Federal Maritime Commission (FMC) describes an ocean freight forwarder as a US-based individual or company that arranges the movement of cargo, dispatches shipments and prepares documentation. FMC also states that such a forwarder must obtain a license from FMC (46 CFR 515.3) and submit proof of financial responsibility for payment of claims (46 CFR Part 515, Subpart C). Those two items can be asked for by name. Source: FMC, Ocean Transportation Intermediaries, checked 2026-11-01.
A related role is the non-vessel-operating common carrier. FMC defines an NVOCC as a common carrier that holds itself out to the public to provide ocean transportation, issues its own house bill of lading and does not operate the vessels. US-based NVOCCs must be licensed and show financial responsibility. See the CASRAI guide to the NVOCC for the term in more depth.
Who does what: forwarder, NVOCC, customs broker, importer
| Party | What the cited source says | Source |
|---|---|---|
| Ocean freight forwarder | Arranges cargo movement, dispatches shipments, prepares documentation; FMC license and proof of financial responsibility required | FMC |
| NVOCC | Common carrier that issues its own house bill of lading and does not operate vessels; US-based NVOCCs must be licensed and show financial responsibility | FMC |
| Customs broker | Holds a license to conduct customs business on behalf of other persons; licensing authority is section 641, rules in 19 CFR Part 111 | CBP |
| Importer / consignee named on the entry | Named in the entry data that FDA reviewers compare with the declared manufacturer, product description and Affirmation of Compliance codes | FDA |
Freight forwarder vs customs broker
They are licensed by different bodies for different activities. FMC licenses ocean freight forwarders and NVOCCs; CBP licenses customs brokers to conduct customs business on behalf of other persons under section 641 and 19 CFR Part 111. A single company can hold more than one role, so ask which license covers which service in your quote rather than assuming. For the broker side, see customs broker license, and for the party legally responsible for the entry, importer of record. Agree in writing which party transmits the entry data.
What FDA checks on a device import entry
FDA’s page on importing medical devices states that firms making or distributing devices for US commercial distribution must register annually and that most registered establishments must also list their devices. FDA reviewers compare the entry against the declared manufacturer, importer or consignee, product description and Affirmation of Compliance codes, using the information in the importer’s entry transmission. Inaccurate or incomplete information may delay review. If the data do not match, FDA may gather more information or detain the product, and a product without required registration and listing is subject to refusal. Source: FDA, Importing Medical Devices, checked 2026-11-01.
One detail is easy to miss: to obtain a listing number you have to contact the firm that listed the device. Ask the manufacturer or listing firm for it early. The full entry-review sequence is in importing medical devices into the US.
What to verify before hiring
- The forwarder’s FMC license, if it arranges ocean shipments, and its proof of financial responsibility.
- The NVOCC license and the party that issues the house bill of lading, if one is used.
- Whether a CBP-licensed customs broker is engaged, and who that is.
- Who is named as importer or consignee, and who transmits the entry data.
- That the manufacturer name, product description, registration and listing details and Affirmation of Compliance codes you supply match what FDA holds.
- Written responsibility for any temperature-controlled or hazardous-goods handling (see below).
Temperature and dangerous-goods handling
Some device shipments need controlled conditions or contain regulated materials. This page does not set handling rules for them. The CASRAI guides on good distribution practice (GDP), IATA dangerous goods regulations and dry ice shipping regulations cover those topics; ask the forwarder in writing which of them it applies.
Common mistakes
- Treating the forwarder as responsible for the FDA data. The entry data FDA reviews come from the importer’s entry transmission, so confirm who supplies and checks them.
- Expecting the carrier to supply a listing number. FDA says to contact the firm that listed the device.
- Assuming forwarder and customs broker are the same license. FMC and CBP license different activities.
- Accepting a quote without the license and financial-responsibility details above.
FAQ
Do I need a freight forwarder for medical supplies?
No source cited on this page requires one. FMC describes forwarders as arranging cargo movement and documentation; whether you use one is a business decision. The FDA and CBP requirements apply either way.
What is the difference between a freight forwarder and a customs broker?
FMC licenses ocean freight forwarders (arranging movement, dispatch, documentation). CBP licenses customs brokers to conduct customs business for others under 19 CFR Part 111.
What does FDA do if the entry data do not match?
FDA may gather additional information or detain the product; without required registration and listing the product is subject to refusal.
Sources
- FDA, Importing Medical Devices: https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices (checked 2026-11-01)
- CBP, Customs Brokers: https://www.cbp.gov/trade/programs-administration/customs-brokers (checked 2026-11-01)
- FMC, Ocean Transportation Intermediaries: https://www.fmc.gov/resources-services/ocean-transportation-intermediaries/ (checked 2026-11-01)
