Certificate of Free Sale

What is a Certificate of Free Sale?

A Certificate of Free Sale, or CFS, is a document issued by a government authority or other authorized body to describe a product’s legal marketing or registration status in the issuing jurisdiction.

Importing authorities may request it as evidence during medical device registration. A CFS does not replace the destination country’s application, technical review, local representation or labeling requirements.

Who issues a Certificate of Free Sale?

The issuing body depends on the exporting jurisdiction. In Great Britain, the MHRA issues medical device Certificates of Free Sale under its official CFS process.

Eligibility may depend on the manufacturer’s or representative’s location, device registration, conformity marking and current marketing status. Manufacturers should verify that the issuing authority and certificate format will be accepted by the destination regulator.

Is a CFS the same as product approval?

No. A CFS reports specified regulatory facts; it is not a new safety or performance assessment. The MHRA explicitly states that its CFS should not be treated as government endorsement of the products listed.

Likewise, the importing authority can request additional evidence or reject a certificate that does not meet its legal, authentication or validity requirements.

How is a CFS different from an FDA Certificate to Foreign Government?

For legally marketed U.S. medical devices, FDA commonly issues a Certificate to Foreign Government, or CFG, rather than a document titled Certificate of Free Sale. FDA also offers other export certificate types for products with different U.S. marketing statuses.

See the FDA’s official export certificate types and Pure Global’s FDA Certificate to Foreign Government service.

Does a CFS require legalization or an apostille?

Requirements depend on the destination country. Some regulators accept digitally verifiable certificates; others may request notarization, legalization, an apostille, a recent issue date or specific device and manufacturing-site details.

Manufacturers should confirm these requirements before ordering the certificate. CFS evidence frequently supports registrations in markets such as Brazil, Colombia and Mexico, while the issuing process depends on the source jurisdiction, including the United Kingdom or United States.