Who Needs Export Certificates?
Many U.S. exporters of FDA-regulated products need an Export Certificate for one or more of their products because the government of the importing country requires a specific Export Certificate before they allow a product into their country, issue a permit or registration, or provide a necessary approval. Other exporters need an Export Certificate because their foreign customers require an Export Certificate as assurance of product quality and status in the United States.
Foreign customers and foreign governments seek FDA Export Certificates because they are aware of Food and Drug Administration (“FDA”) reputation as a highly developed regulatory agency. An Export Certificate provides the importing nation with official assurance that products entering their countries meet specific U.S. quality and safety regulations, for example FDA current Good Manufacturing Practice (cGMP) regulations.
Export Certificates will become more essential to all exporters as globalization increases. International efforts to harmonize regulations and shear necessity have caused the regulatory regimes of developed and developing countries parallel each other. Consequently, nations with parallel regulations and comparable enforcement vigilance have begun to develop a policy of reciprocity where the importing country accepts proof of full compliance with the regulations of the exporting country as proxy for compliance with its own regulations. Export Certificates are an example of this trend, as are USDA Import Permits, which condition importation on the obtaining a health certificate from a veterinarian employed by the government of the exporting country.
Export Certificates are not limited to those products that comply with all FDA requirements. FDA also issues Export Certificates for products that do not meet all of its requirements for marketing in the United States, if the products meet FDA’s “export-only” requirements and the requirements of the importing country.
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.