Certificates to Foreign Governments – FDA CFG is crucial to expanding your business into foreign markets. In fact, many Asian, Middle Eastern, & Latin American countries require a CFG in order to sell medical devices within their borders. As a US domestic company registered with the FDA, Dawa Medical will conduct the entire procurement process for you.
- The establishment must be registered with the FDA;
- The device must be listed with the FDA;
- The device must have a cleared Premarket Notification [(510(k)] , an approved Premarket Approval (PMA) Application (unless exempted by regulation), is a device that was on the market prior to May 28, 1976 (before the Medical Device Amendments to the FD&C Act), or was granted a De Novo classification;
- The device must meet the labeling requirements of Title 21 Code of Federal Regulations (CFR) Part 801 (21 CFR 801) or 21 CFR 809, if applicable;
- The device must be manufactured in accordance with the Quality System (QS) regulation of 21 CFR 820, unless exempted by regulation.