INTERNATIONAL TRADE LAW
Classifying Medical Devices for Export
Classifying a medical device for export runs on three separate tracks: its Schedule B commodity code, its FDA export pathway, and its export-control status under the Export Administration Regulations. A device can be perfectly classified for tariff purposes and still be stopped because the FDA pathway was wrong. Work all three before you ship.
Three Layers for Every Device
The three questions are determined by different agencies and do not substitute for one another. The FDA pathway is the one exporters most often overlook.
| Layer | Question it answers | Agency |
|---|---|---|
| Commodity code | Schedule B number for export reporting | U.S. Census Bureau |
| FDA export pathway | May the device be exported, and under what certificate | FDA / CDRH |
| Export-control status | ECCN or EAR99; is a license required | BIS (Commerce) |
The Commodity Code
Most finished medical devices are classified in Chapter 90 of the Harmonized System (instruments and appliances), with some disposables and reagents falling in Chapters 30, 38, or 39 depending on what they are. The device’s function and material control the heading, not its brand or marketing name. Report the resulting Schedule B number in your Electronic Export Information. For the underlying method, see how to classify your goods for export.
FDA Export Pathways
Whether a device can be exported depends first on whether it is legally marketed in the United States. The FDA’s Center for Devices and Radiological Health (CDRH) issues export certificates that document a device’s status for the importing country. The right certificate depends on the device’s U.S. marketing status and class.
| Certificate | When it applies |
|---|---|
| Certificate to Foreign Government (CFG) | Device is legally marketed (cleared or approved) in the U.S. |
| Certificate of Exportability — §801(e)(1) | Device is not legally marketed; Class I, Class II, or exempt by regulation |
| Certificate of Exportability — §802 | Device is not approved; Class II or III meeting the §802 conditions |
A device that is cleared or approved in the U.S. is generally exportable, and a CFG documents that status for foreign buyers and regulators. A device that is not legally marketed can still be exported, but only through the §801(e)(1) or §802 pathway, each with its own conditions on the device’s class and destination. CDRH now issues these certificates electronically. Confirm the importing country’s own registration rules too — a U.S. certificate does not replace foreign approval.
The Export-Control Status
Separate from the FDA question, decide the device’s export-control classification. Most ordinary medical devices are EAR99 — subject to the Export Administration Regulations but not listed under any Export Control Classification Number, so no license is needed for most destinations. But this is not automatic. Devices with controlled features — certain imaging, laser, encryption, or dual-use components — can carry an ECCN that requires a license to some destinations. Screen the end user, end use, and destination even for an EAR99 device. See understanding ECCNs.
Frequently Asked Questions
Does an FDA export certificate replace foreign approval? No. A CDRH certificate documents the device’s U.S. status for the importing country’s authorities. The destination country still applies its own registration and approval requirements.
Can I export a device that is not cleared or approved in the U.S.? Often yes, but only through the §801(e)(1) or §802 pathway, depending on the device’s class and whether it meets the statutory conditions. These pathways carry requirements that a legally marketed device does not face.
Are medical devices export-controlled? Most are EAR99 and ship without a license to most destinations. Devices with controlled technology or components can carry an ECCN. Always screen the destination, end use, and end user.
What Schedule B chapter do medical devices fall in? Most finished devices sit in Chapter 90; some disposables, reagents, and plastics fall in Chapters 30, 38, or 39. The device’s function and composition decide the heading.
Exporting medical devices? Reidel Law Firm prepares flat-fee import/export compliance memos and advises exporters on classification and export controls with direct attorney access. Get an export compliance memo →
