Exporting Legally Marketed Devices
Any medical device that is legally in commercial distribution in the U.S. may be exported anywhere in the world without prior Food and Drug Administration (FDA) notification or approval. 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 the FDA;
- The device must be listed with the 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 System (QS) Regulation of 21 CFR Part 820 (also known as Good Manufacturing Practice or GMP), unless exempted by regulation.
In addition, the U.S. exporter must comply with the laws of each importing country.
Certificates for Foreign Government
While FDA does not restrict the export of legally marketed devices, certain importing countries may require written certification that a firm, or its devices, is in compliance with U.S. law. In these cases, U.S. firms can request an FDA Certificate for Foreign Government (CFG), formerly called Certificate for Products for Export or Certificate of Free Sale.
The CFG is a self-certification process. By completing the required form, a firm certifies that it is registered and listed, 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.
For directions on obtaining Certificates for Foreign Government please see the How to Request Export Certificates/Permits and Submitting Simple Notification section.