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CFG FDACertificate to Foreign Government | FDA CFG

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.

Certificate to Foreign Government for Device not exported from the United States

A Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE) may be issued for medical devices manufactured outside of the U.S. that are cleared, approved, or are not required to submit a premarket report, and are shipped from outside of the U.S. to another foreign country provided certain conditions are met.

Requirements:

  • 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.

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The certificate is valid for a 2 years period.
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