Types of Export Certificates

There are seven types of certificates that FDA provides covering all types of FDA regulated products. Some products qualify for multiple certificates from FDA.

  • “Certificate of Free Sale” (or “Certificate of Export for Seafood”) is for food, including dietary supplements, and cosmetic products that may be legally marketed in the United States. (CFSAN) 
  • “Health Certificates for Food/Feed” currently required primarily by the European Union (EU), are usually consignment-specific and often contain language pertaining to “compliance” of the particular product/consignment with foreign regulations. As a matter of policy, FDA does not issue export certificates that attest to compliance with another country’s requirements. Rather, FDA may work with other governments to develop mutually acceptable language for the certificate, e.g., language recognizing “equivalence” rather than “compliance.” (ORA-Field Offices)
  • “Specified Risk Materials of Bovine, Ovine and Caprine Origin Certificate” is used for the export of gelatin that can be legally marketed in the United States. These certificates address concerns on raw material in regard to transmissible bovine spongiform encephalopathy (“BSE”). (CFSAN)
  • “Certificate of a Pharmaceutical Product” conforms to the format established by the World Health Organization (WHO) and is intended for use by the importing country when considering whether to license a product for sale. (CBER, CDER, and CVM)
  • “Non-Clinical Research Use Only Certificate” is for the export of a product, material, or component, for non-clinical research use only, that is not intended for human use and which may be marketed in, and legally exported from, the United States under the Act. These non-clinical research use only materials will be labeled in accordance with 21 CFR 809.10(c)(2) or 21 CFR 312.160, as appropriate, and exported as they are presently being sold or offered for sale in the United States. (CBER and CDRH)
  • “Certificate to Foreign Government” is for the export of human drugs and biologics, animal drugs, and devices that can be legally marketed in the United States. (CBER, CDRH, and CVM)
  • “Certificate of Exportability” is for the export of human drugs and biologics, animal drugs, and devices that cannot be legally marketed in the United States, but meet the requirements of sections 801(e) or 802 of the Act and may be legally exported. (CBER, CDRH, and CVM)

Identifying and obtaining the right Export Certificate for your products can be essential to smoothly exporting your goods, and avoiding detentions and refusals at foreign ports. Our team of consultants and affiliated attorneys at FDAImports.com has the knowledge and experience to quickly identify and obtain the right export certificate for your products.