Medical Devices - Certificate to Foreign Government (CFG)

A Certificate to Foreign Government (CFG) is a document prepared by the FDA issued for legally marketed devices in the U.S. that are in compliance with the regulations of the FD&C Act.

Medical devices that are legally marketed in the United States can be exported anywhere in the world without getting approval from the FDA. Although the FDA does not restrict the export of legally marketed, certain importing countries require a certification from the FDA stating that the firm or its devices are in compliance with U.S. FDA regulations. Foreign governments will ask for official assurance that the products exported to their countries are in compliance with US FDA regulations such as Good Manufacturing Practice (GMP) requirements. In that case, U.S. companies can request a certificate to foreign government (CFG), also known as a Certificate of Free Sale to the FDA.

The certificate to foreign government (CFG) is a self-certification process. By completing the required form, a firm confirms that it is registered with the FDA and listed its device with the FDA, that each product is legally marketed in the U.S. and is not the subject of an open recall, that all facilities involved in the manufacturing process are complying with the FDA’s regulations, and that each product is being exported from the U.S.

Requirements to get the Certificate to Foreign Government (CFG)

• The manufacturing facility must have a valid medical device establishment registration.
• All devices must be listed with the FDA.
• The devices must have cleared Premarket notification (510K) or Premarket Approval (PMA) unless it is exempted by the regulation.
• The device should meet all the medical device labeling requirements as of 21 CFR 801 and 809.
• The device should be manufactured in accordance with 21 CFR 820, also known as Good Manufacturing Practice, unless it is exempted by the regulation.

A Certificate to Foreign government can be requested through the CECATS system. It is a voluntary electronic system that allows the manufacturers and initial importers to request export documents online. CECATS can be accessed by logging into the FDA account.

The fee for the export certificate from CDRH is $175 for the first certificate and $85 each for an additional certificate upon request from the customer.

Liberty Management Group Ltd., a leading FDA consulting firm in the USA, provides assistance with FDA Medical device registration, device listing, and certificate to foreign government applications.