By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has stopped notarizing Center for Devices and Radiological Health export certificates including Certificates to Foreign Government (CFG), Certificates of Exportability and Non Clinical Research Use Only 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 regulator 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 for imported medical devices from the US in order to be sold legally in their countries.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.