FDA Certificate to Foreign Government (CFG) for Medical 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.
What Is an FDA CFG for medical devices?
A CFG is a snapshot of your company’s medical device compliance status in the US. It serves as proof that you meet the following requirements:
Your US facility is FDA‑registered, and your device is FDA‑listed
Your device has legal US marketing status via 510(k), PMA, De Novo, or pre‑1976 authorization
You follow FDA labeling rules
You comply with FDA quality systems (21 CFR Part 820)
Your device is not the subject of a recall
A CFG only applies to devices legally marketed in the US. If your device is pending or unapproved, it doesn't qualify for a CFG. Instead, you’d need a COE under 801(e)(1) or 802, depending on class and export intent (e.g., if you’re exporting for non-clinical research).
How to Request a CFG from the FDA
CFGs and other export documents are obtained through FURLS CDRH Export Certification Application & Tracking System (CECATS), the agency’s online portal for export certificate requests. The process is fairly straightforward, but missing information, formatting errors, or outdated listings can delay your approval. Here’s what you need to know to submit a complete CFG application:
Access CECATS: Log in via FDA FURLS and access the CDRH Export Certification Application and Tracking System.
Complete all required sections and add product list: Include requester info, manufacturer/distributor details, device listing, recall history, target countries, export intent, and your certification statement.
Submit and pay fees: If FDA issues within 20 business days, fees apply (around $175 for the first, $85 for each additional request).
Receive your CFG: All certificate request reviews completed by the FDA will be issued electronically as downloadable PDFs. FDA will email your application's approval, and you'll have 45 days to download and print (make sure to print in color if apostille is required in your target market).
The US FDA processes requests usually within 20 working days if fees are paid and there are no issues in your application file.
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Don’t let CFG paperwork slow you down or risk your international launch. Pure Global steps in to handle every detail, from CECATS paperwork and fees to post‑certification print and apostille services. We ensure your Certificate to Foreign Government is delivered accurately, on time, and fully compliant with foreign requirements.
Frequently asked questions
Yes, but each certificate is limited to 25 pages, including product listings and attachments. If your product list exceeds that limit, you’ll need to submit a separate application and pay an additional fee for each extra certificate.
Possibly. If the change is significant, like a new trade name, different intended use, or revised manufacturer details, you may need to submit a new CFG request. Minor updates, such as branding tweaks or cosmetic changes, generally do not require a new certificate unless they impact the way the device is presented for regulatory review abroad.
No. The FDA does not offer an expedited process for CFGs. Most certificates are issued within 20 business days if the application is complete, and there are no compliance concerns. The best way to avoid delays is to ensure your device listing is up to date, your submission is accurate, and your payment is processed promptly.
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When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
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