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If a foreign government requires an export certificate for a medical device, how do I get one?
While FDA does not place any restrictions on the export of these devices, certain countries may require written certification that a firm or its devices are in compliance with U.S. law. In such instances FDA will accommodate U.S. firms by providing a Certificate for Foreign Government (CFG). These export certifications were formerly referred to as a Certificate for Products for Export or Certificate of Free Sale. The CFG is a self certification process that is used to speed the processing of requests. Original certificates will be provided on special counterfeit resistant paper with an embossed gold foil seal. CDRH requires an initial fee of $175.00 per certificate and $15.00 per certificate for additional certificate(s) issued for the same product(s) in the same letter of request. Original certificates will be provided on special counterfeit resistant paper with an embossed gold foil seal. You should submit your request for a CFG on form FDA-3613, Supplementary Information Certificate to Foreign Government Requests. Questions regarding the CFG should be directed to the Office of Compliance, Export Certificate Team, at 240-276-0132. (exportcert@cdrh.fda.gov)
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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