Last reviewed: October 26, 2026
FDA's Certificate to Foreign Government (CFG), sometimes called a free sale certificate, proves to other regulators that your device may be legally sold in the US. FDA issues it online for $175, and devices made and shipped outside the US get a version called the CFG-NE.
Key takeaways
- FDA charges $175 for the first certificate and $85 for each additional certificate from the same request. The law gives FDA 20 days to issue it, which FDA reads as 20 working days.
- Devices cleared through a 510(k), approved through a PMA or HDE, granted De Novo, or exempt can qualify. Among other conditions, every establishment must be registered and every device listed.
- The law behind the CFG-NE was signed on December 29, 2022. It covers devices made outside the US and shipped to another country without passing through the US, if the device is also imported or offered for import into the US.
- Certificates are PDFs, valid for 2 years, and foreign regulators can check each one through its QR code.
- India, Taiwan, Brazil, Colombia and Mexico accept a US free sale certificate in some device files, in some cases alongside a home-country document. Singapore and Malaysia rely on the FDA authorization itself.
How does FDA clearance help you sell in other countries?
Other regulators ask for proof that a trusted regulator already allows your device on the market. All nine we checked name FDA or the US, or, in Mexico's case, a group of regulators that includes FDA [9, 10, 11, 12]. The CFG is FDA's official proof of your device's US status, and in several of those files it is the document that carries your FDA clearance.
FDA says exporters "are often asked by foreign customers or foreign governments" for proof of a device's US regulatory or marketing status [2]. A clearance letter shows that one 510(k) was cleared. A CFG goes further. It certifies that the device may be legally marketed in the US, and it carries a manufacturers' page and a product list [2, 3].
This matters for exempt devices. A 510(k)-exempt device has no clearance letter at all, so the CFG is the FDA document you can show a foreign regulator.
Foreign regulators use FDA evidence in two ways:
- As a required document. The registration file must include a free sale certificate or marketing authorization from a reference country.
- As a key to a shorter route. Some regulators run a reliance, abridged or equivalence route for devices already authorized by FDA or other reference regulators.
A CFG is not a foreign approval. Each country decides what it accepts and runs its own review. FDA evidence carries more weight when your home regulator is not on other countries' reference lists. Our article on WHO-listed authorities explains how regulators decide whose approvals to rely on.
Which countries ask for FDA evidence?
It depends on the country, and on which FDA document it wants. Some regulators ask for a free sale certificate, and that is where the CFG fits. Others run a shorter route for FDA-authorized devices, and there the 510(k), De Novo or PMA itself is the key document. We checked each regulator's own rules on October 26, 2026 [9, 10, 11, 12].
Where an FDA free sale certificate is asked for
| Country (regulator) | What the rules ask for | Notes |
|---|---|---|
| India (CDSCO) | For an import license (Form MD-14): a free sale certificate or marketing authorization from the US, UK, EU, Canada, Japan or Australia, plus one from the country of origin if it exists [10] | Copies must be notarized [10] |
| Taiwan (TFDA) | For Class 2 and 3 imports: a manufacture and free sale certificate from the country of origin. It may be replaced by a manufacturing certificate from the home government together with a free sale certificate from the highest health authority of the US or an EU member state [10] | Valid 2 years from issue, and authenticated by a Taiwan overseas office unless TFDA waives this. TFDA does not name the CFG [10] |
| Brazil (ANVISA) | For Class III and IV registration: proof of registration or a free sale certificate from the country where the device is made and sold, or only sold [12] | Apostilled or consularized, and issued within 2 years if the document shows no expiry date. Class I and II notification does not ask for one [12] |
| Colombia (INVIMA) | A certificate from the home regulator. If the device is not used at home, add a certificate that it is freely sold in a reference country, such as the US [12] | For Class I, IIa and IIb, a reference-country free sale certificate no older than 1 year can replace some technical items [12] |
Where your FDA authorization opens a shorter route
| Country (regulator) | Which FDA authorizations count | What it shortens |
|---|---|---|
| Singapore (HSA) | 510(k), De Novo or PMA, for the same labelled use. 510(k)-exempt devices do not qualify [11] | Abridged review targets: 100 working days for Class B against 160 for full review, 160 against 220 for Class C, not counting time waiting on you [11] |
| Malaysia (MDA) | 510(k) or PMA [11] | A verification route. A conformity assessment body checks the file first (about 1.5 months on MDA's timeline), then MDA's target is 30 working days from a complete, paid application [11] |
| Brazil (ANVISA) | 510(k), PMA or De Novo, for first registrations of Class III and IV devices [12] | ANVISA may use FDA's review as its reference. It does not move you up the queue, and no review time is set [12] |
| Mexico (COFEPRIS) | Decisions of regulators from countries on the management committee of the International Medical Device Regulators Forum (IMDRF), which includes FDA. The guidelines do not name the 510(k), PMA or De Novo [12] | Abridged route COFEPRIS-04-050: COFEPRIS checks that the file is complete, with a 30-business-day maximum. The file includes a certificate of free sale or equivalent from that regulator [12] |
| Saudi Arabia (SFDA) | FDA is a named reference regulator. The route excludes "Products granted market access primarily by demonstrating substantial equivalence to a predicate device", and self-registered products [9] | Reliance review of 35 to 60 working days for a complete application [9]. A 510(k) device may need SFDA's standard route instead |
Four details change what you should plan for:
- Saudi Arabia's reliance route may not cover a 510(k). SFDA's guide of September 9, 2026 does not name the 510(k), but it excludes "Equivalence to a Predicate Routes" [9]. It also says software and AI-enabled devices may be excluded. Ask SFDA before you plan on reliance.
- Mexico changed its FDA route in 2025. The old FDA equivalence filings closed in October 2025, under an agreement published on August 22, 2025 [12]. Use the abridged route under the July 18, 2025 guidelines instead.
- Exempt devices miss the shorter routes. Singapore says devices exempt in a reference agency do not qualify [11]. Malaysia lists only the 510(k) and PMA [11], and Saudi Arabia excludes self-registered products [9]. For exempt devices, plan around the free sale certificate instead.
- Some countries want a home-country certificate. The UAE's Emirates Drug Establishment asks for a conformity certificate or marketing authorization, such as a CE certificate, 510(k) or PMA. It also asks for a free sale certificate from the country of origin, certified by the UAE Embassy [9]. For a device made outside the US, plan on a home-country certificate there.
Taiwan, Mexico, Brazil, Colombia, India and the UAE also set rules on how old the document can be, or how it must be notarized, legalized or translated [9, 10, 12]. Check the regulator's current checklist before you request the certificate, so you order the right number of copies at the right time.
Which devices qualify for a CFG?
Devices that may be legally marketed in the US, made at registered establishments that comply with FDA's requirements. When you request a CFG-NE, for example, you certify that [3]:
- each device is made by an establishment located outside the US
- each device is imported or offered for import into the US
- the device is the subject of a 510(k), an approved PMA, an approved humanitarian device exemption or a granted De Novo request
- or it was in commercial distribution before May 28, 1976, or is exempt from premarket notification
- every establishment on the certificate is registered, and has listed every device on it
- no device is the subject of an open import alert, recall, seizure, injunction or other open FDA enforcement action
- every manufacturer, contract manufacturer and contract sterilizer involved is identified
- every establishment operates in substantial compliance with FDA's manufacturing requirements for the device
For an ordinary CFG, FDA also asks for [4]:
- the registration or owner/operator number of everyone involved in design and manufacture
- the product code and marketing status of each device
- any recalls in the past 10 years
Exempt devices qualify. Our guide to whether your device is 510(k) exempt explains how to check. Registration and listing come first, and our FDA registration and listing guide covers both.
What is a CFG-NE, and do you need one?
A CFG-NE is the certificate for devices made outside the US and shipped from there to another country. Section 3304 of the Consolidated Appropriations Act, 2023, signed on December 29, 2022, created it by amending section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [3].
Before that change, a device made in Korea and shipped from Korea to India could not get an FDA certificate. Now FDA can certify such a device. The establishment must be registered and the device listed. The device must be cleared, approved, granted or exempt. And it must be "imported or offered for import into the United States" (21 U.S.C. 381(e)(4)(F)) [1].
If your device is shipped from outside the US, the CFG-NE is your only option. FDA says these manufacturers "may not receive export certificates (such as CFGs)" [3]. The CFG-NE carries the same material information, and its title must include the words "Certificate to Foreign Government" [1].
Registration and listing alone are not enough. FDA explains why: it "does not have authority over devices that are not imported or offered for import into the United States" [5]. If the device is not imported or offered for import into the US, FDA says it likely has no jurisdiction and cannot certify it [5].
The potential reach is large. We measured active foreign establishments and their device listings in FDA's registration files dated October 26, 2026 [8]. Establishments include contract manufacturers and sterilizers:
| Country | Active registered establishments | Device listings | Listings with a premarket number | Listings with no premarket number |
|---|---|---|---|---|
| South Korea | 894 | 5,717 | 3,224 | 2,493 |
| Taiwan | 623 | 5,179 | 1,950 | 3,229 |
| India | 388 | 6,150 | 2,192 | 3,958 |
| Japan | 529 | 4,041 | 2,523 | 1,518 |
| Malaysia | 254 | 3,057 | 1,209 | 1,848 |
| Turkey | 92 | 1,189 | 817 | 372 |
The premarket number field holds 510(k), PMA, De Novo and a few other FDA numbers. Exempt devices are listed without one, and they can still qualify. But no number does not always mean exempt. In Malaysia, 1,173 of the 1,848 listings with no number are for device types that need a 510(k) or PMA. Of those, 1,167 are contract manufacturing or sterilizing listings, where the number sits with the brand owner [8]. Any listed device that meets the other conditions can be named on a CFG-NE [1, 3].
How do you get a CFG, step by step?
You request it online, through FDA's CDRH Export Certification Application and Tracking System (CECATS) [3, 4]. Plan for these steps:
- Register and list first. Every establishment involved must be registered, and must list each device on the certificate. If a listing is missing, CECATS cannot show the device until you update your registration [5].
- Log in to CECATS. You reach it through FDA's Unified Registration and Listing System (FURLS), with your establishment's account [3].
- Answer the export question. Answer "Yes" to "Will the devices be exported from the United States?" for a CFG. Answer "No" and CECATS opens the CFG-NE application [3, 4].
- Enter the details. You need the registration or owner/operator number for the manufacturer, and the product code and marketing status, with clearance or approval date, for each device [3].
- Upload the product list. FDA provides an Excel template. Each certificate is limited to 25 pages, including the attachment pages [5].
- Sign the certification statement. For a CFG-NE, you sign a Shipper's Certification Statement. For a CFG, an Exporter's Certification Statement [3, 4].
- Answer any questions within 48 hours. If FDA returns your request for action, you have 48 hours to make changes. After that, the status becomes "incomplete" and you must clone and resubmit [5].
- Download it within 45 days. FDA emails you when it is issued. You get one chance to print or download each certificate, within 45 days of issue [6].
Since January 2, 2024, FDA issues every device export certificate as a PDF [6]. If you send a paper request, FDA will ask you to use CECATS [3].
How much does a CFG cost, and how long does it take?
The first certificate costs $175, and each additional certificate from the same request costs $85 [2]. The law tells FDA to issue a certification within 20 days, and caps the fee at $175 for each certification issued within that time [1].
| Item | Detail |
|---|---|
| Fee, first certificate | $175 [2] |
| Fee, each additional certificate from the same request | $85 [2] |
| Page limit | 25 pages per certificate. $175 is charged for each 25-page increment [2, 3] |
| FDA's example | 8 copies of a 10-page certificate cost $1,040 [2] |
| Billing | FDA invoices quarterly for certificates issued that quarter [2] |
| Time limit | 20 days in the statute [1]. FDA reads this as 20 government working days [7] |
| Validity | 2 years from the date issued [6] |
| Download window | 45 days after issue, one time only [6] |
Order every copy you need in one request. Each certificate has its own number and QR code, and FDA's FAQ says each certificate number "can only be authenticated once" [5]. If three countries each need an apostilled original, ask for three. FDA counts pages across all copies: every 25 pages is charged as a $175 original, and the other copies cost $85 each [2]. A new request starts again at $175.
Print apostilled copies in color. FDA says apostilles and authentications must be printed in color to be valid [6]. The US Department of State issues the apostille, and FDA does not notarize export certificates [2, 5]. FDA recommends its online validator as the main way to authenticate a certificate [2].
Regulators can check it online. Anyone can verify an electronic certificate through FDA's FURLS Export Certificate Validator, using the QR code or the web address on the certificate [2]. The validator shows the establishment, certificate type, expiration date and an image of the certificate [2].
What can stop FDA from issuing a CFG?
Open enforcement problems and quality system failures. Among the grounds FDA names are four: an injunction, a seizure, a Class I or Class II recall, or an establishment out of compliance with 21 CFR part 820 [7].
For a CFG-NE, FDA may also deny the request if a condition of section 801(e)(4)(F) is not met [7]. One example: the device is not imported or offered for import into the US.
FDA must explain a denial in writing [1]. For a quality system denial, it sends a summary of the specific problems [7]. FDA says it "does not intend to deny" a certificate when the most recent quality system inspection was classified NAI or VAI [7]. NAI means No Action Indicated, and VAI means Voluntary Action Indicated.
You can ask FDA to review a denial. For devices regulated by CDRH, send the request to the Exports Team within 60 calendar days of the denial [7]. FDA says the review may take up to, or more than, 30 days [7].
A Form FDA 483 alone is not grounds for denial if you and FDA have agreed on a plan of correction [1, 7]. FDA says it generally intends to respond to a plan of correction within 90 days [7]. After an inspection classified Official Action Indicated (OAI), you can apply again once FDA finds your corrections adequate [5].
What do manufacturers outside the US get wrong?
Each of these comes from FDA's own rules:
- Assuming registration is enough. For a CFG-NE, the device must also be imported or offered for import into the US [1, 3].
- Ordering one certificate for three countries. Each certificate number can only be authenticated once [5].
- Missing the download window. You get one download, within 45 days of issue [6].
- Printing in black and white. Apostilled copies must be printed in color [6].
- Leaving out a site. Every manufacturer, contract manufacturer and contract sterilizer must be identified, and each must be registered and list the device [3].
- Ignoring an open recall. A Class I or Class II recall can stop the certificate [7].
One more tip: write the product list the way the foreign dossier names the device. FDA's template lets you set the device names as they will appear on the certificate [5].
Planning to sell beyond the US? Complizen handles the FDA side of this: establishment registration, device listing, the US Agent and the export certificate request. Tell us which markets you are targeting, and our International Track covers the rest of the US entry sequence.
Frequently asked questions
What is an FDA Certificate to Foreign Government?
It is FDA's written certification that a device may be legally marketed in the US and meets FDA's requirements. Manufacturers use it when foreign regulators or customers ask for proof of US status. FDA issues it as a PDF through its online export system, CECATS, for $175 per first certificate.
Is a CFG the same as a free sale certificate?
Close to it. The CFG is FDA's version of what India, Taiwan, Brazil, Colombia and Mexico call a free sale certificate. Whether a regulator accepts it depends on its own rules, and some also ask for the 510(k) letter or a home-country certificate. Check the current checklist first.
What is a CFG-NE?
It is a Certificate to Foreign Government for a device not exported from the United States. It is for devices made outside the US and shipped to another country without passing through the US. It carries the same information as a CFG, and its title includes the words "Certificate to Foreign Government".
Can a 510(k) exempt device get a Certificate to Foreign Government?
Yes. Devices exempt from premarket notification qualify, if every establishment involved is registered with FDA and lists the device. For a CFG-NE, the device must also be imported or offered for import into the US. With no clearance letter, the CFG is the FDA document to show a regulator.
Can I get a CFG-NE before I sell in the US?
Only if the device is imported or offered for import into the US. The law covers those devices, and FDA says it likely has no jurisdiction over devices that are not, so it cannot certify them. Registration, listing and clearance alone do not meet this condition.
How much does a Certificate to Foreign Government cost?
FDA charges $175 for the first certificate and $85 for each additional certificate from the same request. Each certificate is limited to 25 pages, and $175 is charged for each 25-page increment. FDA's own example: 8 copies of a 10-page certificate cost $1,040, invoiced quarterly.
How long does FDA take to issue a CFG?
The law directs FDA to issue an export certification within 20 days of receiving the request. FDA reads this as 20 government working days, and it may charge its fee only when it meets the limit. FDA emails you when the certificate is ready to download.
How long is a Certificate to Foreign Government valid?
FDA says its export certificates are valid for 2 years from the date issued. Regulators can verify a certificate through FDA's online validator while it is valid. You get one chance to download or print it, within 45 days of issue, so save the PDF safely.
Which countries accept an FDA Certificate to Foreign Government?
Several accept a US free sale certificate in some device files. India, Taiwan, Brazil and Colombia list US or reference-country certificates, sometimes with a home-country one, and Mexico's abridged route asks for one from the reference regulator. Singapore and Malaysia rely on the FDA authorization itself.
Does FDA apostille or notarize the certificate?
No. FDA does not notarize export certificates. The US Department of State issues apostilles and authentications, and only for certificates printed in color. FDA recommends its online validator as the main way to authenticate a certificate, but check whether your destination still asks for an apostille.
Does Saudi Arabia accept FDA 510(k) clearance?
Probably not for its reliance route. SFDA's guide of September 9, 2026 names FDA, but excludes products that reached the market mainly by showing substantial equivalence to a predicate, which is how a 510(k) works. A cleared device can still apply through SFDA's standard marketing authorization.
Does an FDA certificate guarantee approval in another country?
No. The certificate confirms your device's status in the US. Each country decides what evidence it accepts and runs its own review. Where a reliance or abridged route exists, FDA authorization can shorten the review, but the foreign regulator still makes its own decision.
References
- US Code. 21 U.S.C. 381(e)(4), export certification, including subparagraph (F) on devices not exported from the US. 2024 edition, accessed October 26, 2026.
- FDA. Exporting Medical Devices. Content current as of January 30, 2026.
- FDA. Devices Not Exported from the United States. Content current as of January 2, 2024.
- FDA. How to Request Export Certificates or Permits and How to Submit Simple Notifications. Content current as of January 2, 2024.
- FDA. Exporting Medical Devices: Frequently Asked Questions. Content current as of January 2, 2024.
- FDA. Transition to Electronic Export Documents: Letter to Industry. January 2, 2024.
- FDA. Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices. Guidance issued November 3, 2023.
- FDA. Establishment Registration and Medical Device Listing Files for Download. Registration and listing files dated October 26, 2026, counted by Complizen.
- Gulf regulators. SFDA, MDS-G30 SFDA Reliance Approach for Medical Device, version 1.0, September 9, 2026, and MDS-REQ 1 Requirements for Medical Devices Marketing Authorization, version 6.0, December 19, 2021. Emirates Drug Establishment, Issuance of Marketing Authorization for a Medical Device. Accessed October 26, 2026.
- India and Taiwan. CDSCO, Checklist for the grant of Import license in Form MD-15 (application in Form MD-14). Taiwan, Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration, amended November 27, 2023, Appendix 2. Accessed October 26, 2026.
- Singapore and Malaysia. HSA, GN-15 Guidance on Medical Device Product Registration, revision 15, effective October 1, 2026, Registration overview and Fees and turnaround time for medical devices, updated March 26, 2026. MDA, MDA/GD/0070, registration through conformity assessment by way of verification, second edition, October 2025. Accessed October 26, 2026.
- Latin America. COFEPRIS, abridged regulatory route guidelines, Diario Oficial July 18, 2025, and the agreement removing the FDA equivalence filings, Diario Oficial August 22, 2025. FDA, International Medical Device Regulators Forum (IMDRF), on FDA's seat on the management committee. ANVISA, IN 290/2024, in force June 3, 2024, and RDC 751/2022. INVIMA, Decree 4725 of 2005 and Decree 3275 of 2009. Accessed October 26, 2026.