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Do medical device exports require prior FDA notification or approval?
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions of the FD&C Act only applies to unapproved devices. For a device to be legally in commercial distribution in the U.S., the following requirements must be met: The manufacturing facility must be registered with FDA; The device must be listed with FDA; The device must have a cleared Premarket Notification 510(k) or Premarket Approval (PMA) unless exempted by regulation or if the device was on the market prior to May 28, 1976 (before the Medical Device Amendments to the FD&C Act); The device must meet the labeling requirements of 21 CFR Part 801and 21 CFR 809, if applicable; The device must be manufactured in accordance with the Quality Systems (QS) Regulation of 21 CFR Part 820 (also known as Good Manufacturing Practices or GMP), unless exempted by regulation. In addition, the U.S. exporter must comply with the laws of the importing country. Please note that U.S. manufactures that export medical devices outside the U.S. are required to register their facility and list their devices (21 CFR 807). 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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