FDA Certificate to Foreign Government for Bahrain

FDA Export Certificates in Bahraini Registration Files

Bahrain’s National Health Regulatory Authority (NHRA) and other Bahraini regulators often look to approval in an established reference market when assessing imported health products. For U.S.-made medical devices, foods, dietary supplements and cosmetics, the FDA’s Certificate to Foreign Government (CFG) is the usual way to show that a product is legally marketed in the United States and that FDA has no known compliance concerns about the manufacturer.

Medical devices

Device registration with the NHRA is commonly handled by a local authorized representative or distributor on behalf of the manufacturer. The dossier typically combines the CFG with technical documentation, quality certification such as ISO 13485, labeling and a letter of authorization appointing the local representative. The device names, models and manufacturer details on the CFG must match the rest of the dossier, because a mismatch is one of the most common reasons for queries.

Foods, supplements and cosmetics

For food and supplement imports, Bahraini importers and food safety authorities may ask for proof of free sale, and the CFG serves that purpose for FDA-regulated products. Cosmetics importers increasingly ask for the same. Requirements vary with the product category and change over time, so confirm the current list with your Bahraini partner before ordering certificates.

Federal signature, federal apostille

An FDA official signs the CFG, so it is a federal document. Instead of a notary or a state office, the original is presented as issued to the federal Office of Authentications in Washington, which attaches the apostille. Bahrain has been a party to the Apostille Convention since December 31, 2013, so the federal apostille completes the CFG for use there, with no Bahrain Embassy step.

Ordering and timing

Request one original CFG for each Bahraini registration file and each distributor that needs one, because each original receives its own apostille. Bahraini regulators generally prefer recent certificates, so order and apostille them close to submission. For drugs, the equivalent document is the COPP, and for products not sold in the U.S., the Certificate of Exportability, both of which follow the same federal apostille route.