Certificate to Foreign Government (CFG) is document prepared by FDA issued for legally marketed devices in the U.S that are in compliance with the regulations of FD&C act.
Medical devices that are legally marketed in the United States can be exported to anywhere in the world without getting approval from FDA. Although FDA does not restrict the export of legally marketed, certain importing countries require a certification from FDA stating that the firm, or its devices are in compliance with U.S. FDA regulations. Foreign government will ask for official assurance that the products exported to their countries are in compliance with US FDA regulations such Good manufacturing Practice (GMP) requirements. In that cases, U.S companies can request a certificate to foreign government (CFG) also known as Certificate of Free sale to 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 FDA and listed their device with 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 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 labelling requirements as of 21 CFR 801 and 809.
- The device should be manufactured in accordance with 21CFR 820 also known as Good Manufacturing practice unless it is exempted by the regulation.
Certificate to Foreign government can be requested through 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 FDA Furls account.
The fees for export certificate from CDRH is $175 for the first certificate and $85 each for additional certificate upon the request from the customer.
Liberty Management Group, a leading FDA consulting firm provides assistance with FDA Medical device registration, device listing and certificate to foreign government application.
Sudha S
Regulatory Consultant
Mail : office@libertymanagement.us
fda certificate https://www.fdahelp.us/certificate-of-fda-registration.html
register with FDA https://www.fdahelp.us/register-fda.html
I buy products from a US company, put my label and then export them to other countries. The manufacturer is registered with FDA. But i want to obtain a certificate to foreign government for my products? can i do so? or is it only for manufacturers?
Do the US company is registered with FDA as an initial importer? If you are an initial importer of the product then you need to register with FDA and identify the manufacturer. Also please make sure that the manufacturer is registered with FDA and list their devices. Please provide more details to guide you more.
Can a foreign manufacturer obtain Certificate to Foreign Government? Or is it only for US manufacturers?
Only US manufacturer can apply for CFG