FDA Certificate of Free Sale: What It Is and How to Obtain One

What Is an FDA Certificate of Free Sale?

An FDA Certificate of Free Sale (CFS) — sometimes called a Certificate for Foreign Government, Certificate to Foreign Government, or Certificate of Exportability — is an official document that certifies a product is legally marketed in the United States and meets all applicable FDA requirements.

The name "Certificate of Free Sale" comes from the concept that the product is "free to be sold" in the U.S. market — meaning it has met all local regulatory requirements and is not subject to any restrictions on sale.

Who Needs a Certificate of Free Sale?

Foreign governments in many countries require a CFS as part of the import approval process for FDA-regulated products. Countries and regions that commonly require a U.S. CFS include:

• Middle Eastern countries (UAE, Saudi Arabia, Kuwait, etc.)
• Southeast Asian countries (Vietnam, Thailand, Indonesia, Philippines)
• Latin American countries (Brazil, Colombia, Chile, Peru)
• African countries for food, cosmetics, and medical devices
• China for certain food and cosmetic categories

Requirements vary significantly by country and product type. Some countries require the CFS to be authenticated (apostilled), while others accept it directly.

Types of FDA Certificates

The FDA actually issues several types of certificates, depending on the product type and purpose:

For Drugs

• Certificate for Foreign Government (CFG): Certifies that the drug meets FDA's regulatory requirements
• Certificate of Exportability: For drugs not approved in the U.S. but intended for export

For Medical Devices

• Certificate for Foreign Government: Certifies FDA clearance/approval status and that the device is sold in the U.S.

For Food and Cosmetics

• The FDA does not directly issue a Certificate of Free Sale for food and cosmetics in the traditional sense. Instead, these are typically obtained through state health departments, the FDA's Freedom of Information process, or through your U.S. Agent who can provide verification letters.

How to Obtain an FDA Certificate

1. 1
   Determine the exact certificate required Confirm with the importing country's regulatory authority exactly what document is needed — the specific name, format, and any apostille or authentication requirements.
2. 2
   Ensure your product meets eligibility requirements For drug certificates, the product must typically be approved or cleared for U.S. sale, or meet export eligibility criteria. For device certificates, 510(k) clearance or PMA approval is usually required.
3. 3
   Submit a certificate request to FDA Drug and device certificate requests are submitted to the FDA's Center for Drug Evaluation and Research (CDER) or Center for Devices and Radiological Health (CDRH) via the CertUS electronic system.
4. 4
   Pay the applicable fee FDA certificate fees vary by product type and certificate category. Check the current FDA fee schedule for the applicable fee.
5. 5
   Receive and authenticate (if required) Once issued, if the destination country requires apostille authentication, the certificate must be submitted to the U.S. Department of State or an appropriate state authority for apostille processing.

Regovant's Certificate of Registration

In addition to FDA-issued certificates, Regovant provides clients with a Certificate of Registration confirming their FDA facility registration status, U.S. Agent designation, and registration numbers. This document is widely accepted by foreign buyers, importers, and regulatory authorities as proof of FDA compliance.

Unlike FDA-issued certificates which can take weeks, Regovant's Certificate of Registration is issued within days of successful FDA registration.