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Regulatory Focus™ > News Articles > FDA Changes Process for Exporting Devices to Foreign Markets

FDA Changes Process for Exporting Devices to Foreign Markets

Posted 04 March 2014 | By Alexander Gaffney, RAC

Medical device manufacturers looking to export their products to foreign markets will soon have a slightly different export process to contend with.

As of 1 March 2014, the US Food and Drug Administration's (FDA) Center for Devices and Radiological health (CDRH) will no longer be notarizing device export certificates, FDA has announced.

In a statement, FDA said it is not required by law to either authenticate or notarize export certificates, though it has done so anyway for product exported under 21 USC 381(e)-the part of the US Code that deals with products imported or exported under the Federal Food, Drug and Cosmetic Act.

Under the existing policy, FDA would notarize or authenticate Certificates to Foreign Governments, Certificates of Exportability and Non Clinical Research Use Only Certificates.

As explained by FDA: "FDA export certificates include the signature of an FDA official and an embossed Department of Health & Human Services (DHHS) federal seal. These officially signed and embossed FDA export certificates are considered official and authentic documents that do not require further verification or authentication."

Many governments require these certificates, which typically note that a product conforms to the regulations and standards of the US, or are otherwise eligible to be exported legally.

However, FDA's services are now set to change, with the agency giving up the practice entirely.

Instead, the agency recommends that entities looking for authentication or notarization services utilize the Department of State's Office of Authentication, which it said provides authentication and apostille certificates for a wide range of exporting entities.

The agency did not say if it intends to make similar changes for its drug and biologics divisions in the future.


FDA Statement

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