INTERNATIONAL TRADE LAW
How to Export Medical Devices: FDA Requirements
A medical device that is legally marketed in the United States can generally be exported freely; the harder cases are devices not yet cleared or approved by the FDA, which can still be exported only under specific provisions of the Food, Drug, and Cosmetic Act (FD&C Act). Where your device sits on that line determines what paperwork you need and which export rules apply. This guide explains the U.S. side of exporting medical devices — certificates, quality systems, and export controls — before the destination country’s rules take over.
Devices legally marketed in the U.S. export freely
If your device is cleared (510(k)), approved (PMA), or otherwise legally marketed in the United States, you can export it without special FDA permission. Foreign buyers and their governments, however, often want proof that the device is sold legally here. That proof is a Certificate to Foreign Government (CFG), issued by the FDA’s Center for Devices and Radiological Health (CDRH) for devices that are legally marketed in the U.S.
Devices not cleared or approved can still be exported
A device that is not legally marketed in the U.S. can often still be exported, but only under defined conditions in the FD&C Act. CDRH issues certificates documenting that the export qualifies:
| Certificate | Use |
|---|---|
| Certificate to Foreign Government (CFG) | Device is legally marketed in the U.S. |
| Certificate of Exportability — Section 801(e)(1) | Device not legally marketed in the U.S. that is Class I, Class II, or exempt by regulation and meets the statute’s conditions |
| Certificate of Exportability — Section 802 | Device that may not be legally marketed in the U.S. — including unapproved Class III and certain Class II devices — where the establishment and device meet Section 802’s criteria |
| Non-Clinical Research Use Only Certificate | Device exported for non-clinical research use |
The two export pathways — Section 801(e) and Section 802 — carry conditions on labeling, the importing country’s acceptance, and the device’s safety and effectiveness. Confirm which pathway fits before you ship; exporting an unapproved device outside these provisions is an FD&C Act violation.
Export certificates now issue electronically through CECATS
CDRH issues device export certificates through the CDRH Export Certification Application and Tracking System (CECATS). Since January 2, 2024, those certificates are delivered electronically as downloadable PDFs rather than paper documents. Build the application time into your export schedule — a foreign buyer or customs authority that requires a certificate will not release goods without it.
Quality systems now follow ISO 13485 (QMSR)
The FDA’s device quality requirements changed in 2026. The Quality Management System Regulation (QMSR), which became effective February 2, 2026, amended 21 CFR Part 820 to incorporate the international standard ISO 13485:2016 by reference. The practical effect for exporters is helpful: the U.S. quality-system baseline now aligns with the standard most other markets already use, reducing the gap between FDA expectations and foreign regulators’ expectations. Manufacturers distributing finished devices should confirm their quality system maps to the QMSR/ISO 13485 framework.
The destination country’s rules govern entry
Clearing the U.S. side does not get the device into another market. Each jurisdiction runs its own approval and marking system — the European Union’s Medical Device Regulation (MDR 2017/745) and CE marking, for example, are separate from FDA clearance and often require a local authorized representative. Confirm the destination’s classification, registration, and labeling rules before shipping, and treat ISO 13485 certification as the common ground most foreign regulators expect.
A note on export controls: most medical devices are EAR99 under the Export Administration Regulations and ship without a Commerce license, but some devices and components have specific export-control classifications. Screen every party against the BIS Entity List and OFAC’s SDN list, and confirm the destination is not embargoed.
Frequently asked questions
Do I need FDA permission to export a device I already sell in the U.S.? No. A device legally marketed in the U.S. can be exported without special permission. You can request a Certificate to Foreign Government if the buyer or destination country wants proof of legal U.S. marketing.
Can I export a device the FDA hasn’t cleared or approved? Often yes, under Section 801(e) or Section 802 of the FD&C Act, if the device and establishment meet the statute’s conditions. CDRH can issue a Certificate of Exportability documenting it.
How do I get an export certificate? Apply through CECATS, CDRH’s export certification system. Since January 2, 2024, certificates are issued electronically as downloadable PDFs.
What changed with the QMSR in 2026? Effective February 2, 2026, 21 CFR Part 820 incorporates ISO 13485:2016 by reference, aligning the FDA’s quality-system requirements with the international standard used in many export markets.
For related guides, see how to export toys and machinery export compliance, or our international trade law practice page.
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