FDA Certificate to Foreign Government (CFG) for Devices
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A Certificate to Foreign Government (CFG) is proof that a medical device is legally marketed in the US. CFGs are often required documentation for market entry for countries in Asia, Latin America, the Middle East, and elsewhere. Pure Global can help you obtain a CFG as part of your export strategy to new markets.
Video guide
FDA CFG: Certificates for Device Exports
Find out what an FDA Certificate to Foreign Government covers, when exporters may need it and how requests work.
Open video pageTranscript (English)
Does your export need an FDA CFG? Foreign customers and governments often ask exporters for proof of a device's U.S. status. For legally marketed devices, that proof is a CFG. A Certificate to Foreign Government is only for devices that can be legally marketed in the U.S.: cleared, approved, granted De Novo, exempt, or on the market before May 28, 1976. Other devices use a Certificate of Exportability. When you apply online, you certify that the establishment is registered, each device is listed and legally marketed, and none is the subject of an open recall. You also list recalls from the past 10 years. The fee is set. $175 for the first certificate, $85 for each extra one in the same request, invoiced quarterly. Then you get one download, within 45 days. Start with three things. One: fix registration and listing first. Two: name every manufacturer involved, including contract sterilizers and relabelers. Three: print in color if your market needs an apostille. No U.S. status, no CFG. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.
What is an FDA Certificate to Foreign Government?
A Certificate to Foreign Government (CFG) is an FDA export document requested for eligible medical devices. It provides specified regulatory information for use by a foreign authority. It is not a new product approval, a substitute for the importing country’s registration or an unlimited guarantee of compliance.
Confirm the product’s legal marketing status, establishment information and applicable certificate conditions before applying. The device’s name, models, manufacturer and sites should match registration/listing and the relevant 510(k), De Novo, PMA or exemption basis.
Choose the correct export document
| Situation | Document to assess | Key distinction |
|---|---|---|
| Eligible device legally marketed in the US and exported from the US | CFG | Must meet the certificate’s conditions |
| Eligible device manufactured outside the US and shipped between foreign countries | CFG-NE | Specific certificate for a device not exported from the US |
| Device not legally marketed in the US but eligible for export under the relevant statutory route | Applicable Certificate of Exportability | Eligibility depends on the actual export provision |
| Nonclinical research use | Appropriate nonclinical/research export documentation | Not interchangeable with authorization for clinical or commercial use |
FDA’s export FAQs explain the distinctions. A foreign manufacturer is not excluded merely because it lacks a US manufacturing facility; identify the correct shipment scenario and certificate type.
CECATS application checklist
- Ask the destination authority which certificate, product scope, date, authentication and language it needs. Confirm whether one certificate may cover the proposed product list.
- Reconcile legal names, physical addresses, establishment records, product listings and marketing authorization numbers. Investigate discrepancies before filing.
- Access the CDRH Export Certification Application and Tracking System (CECATS) through FDA Industry Systems and select the correct application.
- Complete the required sections, product attachment and certifications. Keep a controlled copy and supporting compliance records.
- Follow the current fee, review-question and certificate-download instructions. Assign an owner to monitor the application and respond promptly.
The CECATS CFG instructions provide the actual workflow. Fees can depend on certificate type and request details; verify them rather than relying on a generic “additional certificate” price.
Electronic issuance and destination-country acceptance
CDRH transitioned covered export documents to downloadable electronic PDFs from January 2, 2024. Follow FDA’s request and issuance instructions for downloading, preserving and authenticating the certificate. The importing authority’s rules determine any additional legalization, apostille or translation work; electronic issuance does not automatically waive those requirements.
Build schedule allowance for discrepancies and compliance questions. A commonly stated processing period is not a guaranteed issue date, and an agent cannot guarantee that FDA will issue a certificate or that a foreign authority will accept it.
After a device, site or legal-name change, assess whether the certificate and destination dossier still describe the same product. Coordinate export documentation with QMSR records and the target market’s registration plan. Pure Global can reconcile the records and manage the application within the applicable certificate requirements.
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Frequently asked questions
No. It is an export document describing specified regulatory information. The destination authority still applies its own registration, labeling, representation and import requirements, including its rules on certificate acceptance.
A qualifying product may be eligible for a CFG-NE, which is different from a conventional CFG. Confirm the device’s US regulatory status and all conditions of that certificate route.
Covered export documents have been issued electronically as downloadable PDFs since January 2, 2024. Follow FDA’s current retrieval and authentication instructions and separately confirm the destination authority’s documentary requirements.
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