FDA No Longer Notarizing CDRH Export Certificates

US-based Medical device manufacturers planning on exporting their products to countries requiring CFGs should be aware of this administrative change.  According to the FDA, the Agency is under no obligation to notarize export certificates beginning March 1, 2014.  The FDA has provided only signatures of officials and embossed federal seals on export certificates that “are considered official and authentic documents that do not require further verification or authentication.”

However, some foreign governments may still require further authentication than the FDA now issues. Exporters should determine whether their target market regulators require additional US federal notarization or authentication.  If so, firms should contact the US State Department’s Office of Authentication.  Several governments across Latin America, the Middle East and Asia currently require Certificates to Foreign Government  (CFGs) for imported medical devices from the US in order to be sold legally in their countries.

REFERENCE:  Emergo Group; Stewart Eisenhart; 18 MAR 2014

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