Manufacturers exporting their products from the United States are often asked by foreign customers to provide a “certificate” of export for products regulated by the U.S. FDA.
An Export Certificate is an official document containing information about a product’s regulatory and\or marketing status.
The U.S. FDA currently provides the following kind of Export Certificates, which may be beneficial for any brand looking to export :
Certificates of Free Sale
This kind of export certificate is used for dietary supplements, food\beverages, and cosmetic or beauty products that may be legally marketed in the United States.
Health Certificates for Food/Feed
This kind of export certificate is usually consignment based and relays the U.S. FDA Health compliance to the foreign government’s regulations.
Certificate of a Pharmaceutical Product
This kind of export certificate is used to confirm that the pharmaceutical product conforms to World Health Organization (WHO) standards.
Certificate to Foreign Government
This export certificate is used for human drugs, animal drugs, biologic products, and medical devices that are allowed to be legally marketed in the United States.
Certificate of Exportability
This export certificate is used for human drugs, animal drugs, biologic products, and medical devices that are not allowed to be legally marketed in the United States but may be legally exported.