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Certificates of Free Sale / Legalisation of Documents

A Certificate of Free Sale (CFS), sometimes called Free Sale Certificate (FSC), is issued by a Competent Authority, such as the MHRA in the UK or the MCCAA in Malta.

A CFS certifies that a medical device has been CE marked (CE marking) under one of the medical device directives and is available for free sale within the EU/EEA.

Since CE marking is required for market entry into EU/EEA countries, a CFS is not required when exporting to the EU/EEA.

There are many non-EU/EEA countries which require, as supporting documents for local market authorisation, a CFS issued by a Competent Authority. Advena, when appointed as a manufacturer’s EC Rep, is able to provide this important documentation.

In many cases, a Certificate of Free Sale must also be apostilled by the Ministry of Health/Foreign Affairs office and attested by a country’s Embassy/Consulate. Again, Advena is able to facilitate this requirement.

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