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How can I obtain an export certificate for medical devices?
You should submit your request for an export certificate on the appropriate form. FDA-3613, Supplementary Information Certificate to Foreign Government Requests FDA-3613a, Supplementary Information Certificate of Exportability Requests Questions regarding the CFG and the COE should be directed to the Office of Compliance, Export Certificate Team, at 240-276-0132. (exportcert@cdrh.fda.gov) 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. CDRH should to issue the certification within 20 days upon the firm's showing that the product meets the applicable requirements.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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