Export Documentation for Medical Supplies: FDA Certificates, Shipping Papers and What to Ask the Buyer

General information for exporters, lab and clinic staff, and supply teams. It is not legal, regulatory or medical advice.

Short answer

Exporting medical supplies involves three separate layers of paperwork: government certificates or permits from the US Food and Drug Administration (FDA) for US-origin devices, shipment and customs filings such as Electronic Export Information, and whatever the destination country asks the buyer to present. A device that can be legally marketed in the US may be exported anywhere without prior FDA notification or approval, so an FDA certificate is usually something a buyer or foreign regulator asks for, not a gate the exporter must pass first.

Definition and scope

“Export documentation” here means the records that accompany a medical device or device-type supply (for example consumables, dressings or lab products regulated as devices) leaving the United States. Drugs and biologics follow different FDA programs and are outside this guide. The FDA’s Center for Devices and Radiological Health (CDRH) issues four kinds of export certificate; customs and trade filings are handled by other agencies; and each importing country sets its own entry rules.

Which documents answer which question

The quickest way to avoid over- or under-documenting is to ask what each paper is for.

Layer	Question it answers	Typical document	Issued or filed by
1. Regulatory status	Is this device legally marketable in the US, or otherwise lawful to export?	FDA export certificate or permit (see the next section)	FDA CDRH
2. Shipment and customs	What is leaving the country, who is sending it, and what is it worth?	Electronic Export Information (EEI) filed in the Automated Export System (AES); commercial paperwork such as an invoice (see proforma invoice for medical supplies) and a certificate of origin where the buyer requires one	Exporter or its agent; US Census Bureau runs AES
3. Destination country	Will the importing country allow entry and sale?	Whatever the importer’s authority requests, which can include an FDA certificate	Destination authority, via the buyer

Ask the buyer or importer early which layer-3 items they need. The FDA issues the certificates described here; each importing government sets its own requirements.

FDA export certificates by device status

CDRH issues four certificate types, and a separate permit route for devices in a fifth situation. The right one depends on the device’s US status. This table is drawn from the FDA’s page on types of export certificates and its page on how to request them.

Device situation	FDA document	What the FDA page says about it
Can be legally marketed in the US	Certificate to Foreign Government (CFG)	Requires the establishment to be registered and the device listed, a cleared 510(k), approved PMA, De Novo or pre-1976 status, compliant labeling and quality system requirements (21 CFR 820).
Not legally marketable in the US but meets section 801(e)(1) of the FD&C Act	Certificate of Exportability, 801(e)(1)	Class I or Class II devices; the exporter signs a statement, and false statements violate 18 U.S.C. 1001.
Unapproved Class III and certain Class II devices	Certificate of Exportability, 802	Requires conformance with section 802(f) and valid marketing authorization from a Tier 1 country (Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the EU and EEA).
Products for non-clinical research use only, not for human use	Non-Clinical Research Use Only (NCR) Certificate	For products that are legally marketable and exportable under the FD&C Act and intended only for non-clinical research. Relevant to some laboratory consumables.
Device exported under an Export Permit Letter application	Export Permit Letter, 801(e)(2) (a permit, not a certificate)	Application includes a device description, US status, a statement of NLM database search, and a letter from the foreign government liaison, in English or certified translation, confirming no conflict with local law and awareness of the device’s US status.

The FDA notes that a fee is required if a certificate is issued within 20 working days of receiving the request. A related route, the Simple Notification under section 802, asks for the trade name, device type, model number and, if the destination is not a Tier 1 country, the destination country.

Validity depends on the certificate itself and on the importing authority, so check the certificate and ask the authority what age of certificate it accepts.

What each application asks for

• CFG: registration and owner-operator numbers for all manufacturers, product codes and marketing status, any recalls in the past 10 years, a product list, and a signed Exporter’s Certification Statement.
• Certificate of Exportability: registration numbers, device classification, a product list and a signed certification.
• NCR certificate: manufacturer information and a product list.

Requests are made through CECATS, an internet-based application system reached through the establishment’s FURLS account. For how registration relates to listing, see FDA-registered medical device; for the sibling certificate used in many sales, see certificate of free sale for medical devices.

Electronic certificates and verification

Since 2 January 2024 the FDA has issued export documents as downloadable PDFs through CECATS. Foreign governments can validate them through the FURLS Export Certificate Validator (FECV), using a web address or QR code printed on the certificate. Staff should therefore expect a PDF with a verification link or QR code, not a paper original.

Shipment filings

The Census Bureau describes the Automated Export System (AES) as the system for collecting, processing and storing Electronic Export Information from persons exporting goods from the United States, Puerto Rico or the US Virgin Islands. AES is the export component of the Automated Commercial Environment (ACE); filing is done through the free ACE AESDirect portal or through a direct connection. Previously approved companies in the post-departure filing program may report EEI within 5 calendar days after the date of export (post-departure filing). Confirm filing thresholds and exemptions with the Census Bureau or a licensed customs broker. For the import side of the same movement, see importing medical devices into the US and CBP Form 7501.

Common misunderstandings

“We need an FDA certificate before we can ship.”

Not for a legally marketed device. The FDA states that any medical device legally marketed in the US may be exported anywhere in the world without prior FDA notification or approval. The certificate exists because foreign buyers or authorities often ask for evidence of US status.

“A CFG proves the device is FDA approved.”

A CFG is for devices that can be legally marketed in the US, which includes cleared 510(k) and pre-1976 devices as well as approved PMAs. Describe the actual pathway rather than using “approved” for everything.

“One certificate covers every product we ship.”

Each application includes a product list, and the certificate type depends on the device’s US status, so check each product against the table above.

FAQ

Do I need an export certificate to export medical supplies from the US?

Not to export a device that is legally marketed in the US; no prior FDA notification or approval is required. You need one when the buyer, importer or foreign authority asks for it, or when the device is not legally marketable in the US and exports under a specific provision.

Which FDA export certificate applies to laboratory consumables?

Products intended only for non-clinical research, not for human use, can use the Non-Clinical Research Use Only certificate. Items that are regulated devices for human use follow the CFG or Certificate of Exportability routes.

How are FDA export certificates delivered and checked?

As downloadable PDFs issued through CECATS, validated by foreign governments through FECV via a web address or QR code on the document.

What shipping documents go with the FDA certificate?

Customs filings such as EEI in AES and the commercial documents the buyer’s country requires, for example an invoice and, where requested, a certificate of origin. The FDA certificate is separate from these.

Sources

• FDA, Types of Export Certificates, checked 2026-11-01.
• FDA, How to Request Export Certificates or Permits and How to Submit Simple Notifications, checked 2026-11-01.
• US Census Bureau, Automated Export System, checked 2026-11-01.