What is an FDA Certificate to Foreign Government?
A Certificate to Foreign Government (CFG) is an official document issued by the U.S. Food and Drug Administration that certifies certain facts about FDA-regulated products — medical devices, drugs, biologics, or food — for the purpose of export to foreign countries.
Many countries require a CFG before they will allow an FDA-regulated product to enter their market. Regulatory authorities abroad use CFGs as verification that:
- The product is legally marketed in the United States, or
- The facility that manufactures the product is registered with FDA, or
- The product meets applicable U.S. standards
CFGs are not export licenses — they do not grant permission to export. Rather, they are official attestations that foreign regulators use as part of their own product approval or market entry process.
Types of FDA Certificates for Export
FDA issues several types of certificates depending on the product category and what the importing country requires.
1. Certificate for Foreign Government (Medical Devices) — 21 CFR 801.58
For medical devices, FDA issues:
a) Certificate of Exportability Certifies that the device is commercially distributed in the U.S. (i.e., it is legally marketed here). This is the most commonly requested CFG for devices.
b) Certificate to Foreign Government — Not for U.S. Sale For devices that are not marketed in the U.S. but are intended solely for export. These products must meet the requirements of Section 801(e) of the FD&C Act, including:
- Not being in conflict with the laws of the receiving country
- Labeled prominently "For Export Only"
- Not sold or offered for sale in domestic commerce
2. Certificate of Free Sale (Food and Cosmetics)
For food products and cosmetics, FDA issues a Certificate of Free Sale, which certifies that the product is freely sold in U.S. commerce and is not subject to restrictions that would prevent its sale. This is particularly important for exporting to countries in Latin America, Asia, and the Middle East.
3. Drug and Biologic Export Certificates
For prescription drugs, FDA may issue:
a) Certificate of a Pharmaceutical Product (CPP) Follows the World Health Organization (WHO) format and certifies that the product is authorized for sale in the U.S., the manufacturing facility is subject to FDA inspection, and the product information is accurate. CPPs are widely recognized internationally and are required for drug marketing approval in many countries.
b) Certificate of a Drug Product for Export Certifies that the drug product is manufactured in a facility registered with FDA and meets applicable U.S. standards.
How CFGs Help You Enter Global Markets
Regulatory Authority Recognition
Foreign regulatory authorities — including ANVISA (Brazil), COFEPRIS (Mexico), Health Sciences Authority (Singapore), TGA (Australia), and ministries of health throughout Latin America, Asia, and Africa — routinely require CFGs as part of their product registration dossiers.
Without a CFG, your product registration submission may be automatically rejected or delayed indefinitely, regardless of the product's quality or safety profile.
Accelerating Market Entry
In many countries, a valid CFG from FDA can streamline the regulatory review process. FDA's global reputation means that foreign regulators often give expedited consideration to products that carry FDA's attestation — particularly in markets where domestic regulatory capacity is limited.
Demonstrating Compliance
A CFG demonstrates to distributors, healthcare providers, and regulators in foreign markets that your product has been reviewed by one of the world's most rigorous regulatory bodies. This can be a significant competitive advantage in markets where product safety concerns are paramount.
How to Apply for an FDA CFG
Step 1: Determine Which Certificate You Need
Different countries require different certificate types. Research the importing country's requirements before applying. Common sources of this information include the foreign ministry of health's website, your in-country distributor, or a regulatory consultant familiar with the target market.
Step 2: Confirm Eligibility
For most CFG types, the product must be:
- Listed with FDA (for devices and drugs)
- Manufactured in an FDA-registered facility
- In compliance with applicable labeling and manufacturing requirements
Step 3: Submit the Application
CFG applications for medical devices are submitted through FDA's Center for Devices and Radiological Health (CDRH) electronic system. Food and cosmetics certificates are handled through CFSAN. Drug certificates go through CDER or CBER.
Applications typically require:
- Product name and description
- 510(k) clearance number or De Novo number (for cleared devices)
- Establishment registration number
- Labeling samples
- In some cases, a declaration from the manufacturer
Step 4: FDA Review and Issuance
FDA reviews the application and, if all requirements are met, issues the certificate. Turnaround times vary:
- Medical device CFGs: typically 5–10 business days for straightforward requests
- Drug CPPs: can take 4–8 weeks or longer
- Food certificates: typically 2–5 business days
Certificates are valid for 1–2 years depending on type, and must be renewed upon expiration.
Common CFG Mistakes to Avoid
- Requesting the wrong certificate type — each country has specific requirements; a Certificate of Exportability may not be accepted where a WHO-format CPP is required
- Expired certificates — many importers fail to track expiration dates, causing shipment delays at the foreign border
- Mismatched product information — product descriptions on the CFG must exactly match what appears on labels and in registration dossiers
- Applying before establishment registration is current — FDA will reject CFG applications if the facility registration has lapsed
CFG Requirements by Region
| Region | Common Requirement | |--------|-------------------| | Latin America (Brazil, Mexico, Colombia) | Certificate of Free Sale or CPP | | Middle East (Saudi Arabia, UAE) | Certificate of Free Sale + legalization/apostille | | Southeast Asia (Philippines, Indonesia, Vietnam) | CFG + WHO CPP for drugs | | Africa | WHO CPP widely accepted for drugs | | Australia/New Zealand | CFG for devices; less common for food |
Apostille and Legalization
Many countries require that CFGs be apostilled (certified under the Hague Apostille Convention) or legalized through the embassy of the destination country before they will be accepted. This is an additional step beyond FDA issuance and must be factored into your timeline.
How United Regulatory Can Help
We prepare and submit CFG applications to FDA on behalf of medical device, drug, food, and cosmetics companies targeting international markets. We also advise on country-specific requirements, track certificate expiration dates, and manage the apostille and legalization process. Contact us to discuss your export compliance needs.