Certificate of Exportability for Bahrain

Export-Only U.S. Products and Bahraini Regulators

U.S. manufacturers sometimes produce drugs or medical devices specifically for markets abroad: a version with Gulf-specific labeling in Arabic, a strength or configuration approved in Europe but not in the U.S., or a product made under contract for a foreign brand owner. Because these products are not marketed in the United States, the FDA cannot issue a CFG or COPP for them. What it can issue is a Certificate of Exportability, confirming that the product may be lawfully exported under sections 801(e) and 802 of the Federal Food, Drug, and Cosmetic Act.

Why Bahrain may ask for more

Bahrain’s National Health Regulatory Authority (NHRA) generally relies on approval by a recognized reference regulator when it assesses imported health products. A Certificate of Exportability shows that export is lawful, but it does not show U.S. approval or U.S. sale. Expect the NHRA, or your Bahraini importer, to ask for evidence that the product is approved somewhere it trusts, such as a marketing authorization or free sale certificate from another reference country, together with the full technical file. Discuss this with your regulatory consultant or Bahraini representative before you apply, because it may change which certificates you need from which countries.

Which FDA center and what to state

Device exportability certificates are issued by the FDA’s Center for Devices and Radiological Health, and drug exportability certificates by the Center for Drug Evaluation and Research. Name Bahrain as the destination and describe the product exactly as it will appear in the Bahraini file, including the model, strength, pack and labeling version.

Authentication

An FDA official signs the certificate, so it is authenticated federally: the original goes, as issued, to the Office of Authentications at the U.S. Department of State for an apostille. No notary or state office is involved. Bahrain has accepted apostilles since December 31, 2013, so the federal apostille is complete for Bahraini use, and no embassy legalization is needed.

Keep the export record

U.S. export rules expect the exporter to keep records showing that an export-only product meets the importing country’s requirements. For Bahrain, that usually means Arabic labeling that follows Gulf requirements, specifications agreed with the importer, and proof of approval in the reference market. The same records answer most questions a Bahraini reviewer is likely to raise.