Certificate to Foreign Government (CFG) Apostille
What is a Certificate to Foreign Government (CFG)?
The Certificate to Foreign Government (CFG) is an official export certificate issued by the U.S. Food and Drug Administration (FDA). It was authorized under the Export Reform and Enhancement Act of 1996 and certifies that certain medical devices—including radiation-emitting electronic products classified as medical devices—meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for issuing CFGs. These certificates allow U.S. medical device manufacturers to export their products globally, provided the devices are legally marketed in the United States.
Requirements for a Legally Marketed Device in the U.S.
A U.S. establishment may request a CFG if its medical device can be legally marketed. A device qualifies if:
The manufacturer is registered with the FDA.
The device is listed with the FDA.
The device has an FDA-cleared Premarket Notification (510(k)), an approved Premarket Approval (PMA), or has been granted a De Novo classification. Devices on the market before May 28, 1976, may also qualify.
The device meets the labeling requirements under 21 CFR Part 801 or 21 CFR 809 (if applicable).
The device is manufactured in compliance with the Quality System (QS) regulation under 21 CFR 820, unless exempted.
By applying for a CFG, the establishment certifies that:
It is registered with the FDA.
The device is listed with the FDA.
The device can be legally marketed in the U.S.
The device is not under any open recall.
Manufacturing facilities follow FDA regulatory standards.
The device is being exported from the U.S.
How to Apostille or Authenticate a Certificate to Foreign Government (CFG)
A CFG issued by the U.S. Department of Health and Human Services – FDA must often be apostilled or authenticated before it can be used abroad. This ensures that the certificate is legally recognized in the destination country.
Requirements for FDA CFG Apostille or Authentication
The original document must:
Be issued on official FDA letterhead.
Include a legible signature of the authorized official.
Contain the printed name, title, and seal of the issuing agency.
Apostille and Authentication Process
The process is straightforward:
Order the apostille service and prepare your CFG.
If the destination country is a member of the Hague Apostille Convention (1961), the CFG will be apostilled and then accepted abroad without further legalization.
If the destination country is NOT a Hague member, the CFG must first be authenticated by the U.S. Department of State, then legalized at the embassy or consulate of the destination country in Washington, D.C.
Mail or provide the original CFG for processing. Once completed, the apostilled or authenticated document will be returned to you by domestic or international shipping.
Additional Services
Alongside CFG apostille and authentication, we also provide:
Embassy legalization for non-Hague countries.
Apostille services for corporate documents and personal documents across all 50 U.S. states and Washington, D.C.
