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Certificate of Free Sale (CFS) for Medical Devices

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.

In territories outside the EU there seems to be confusion regarding who issues a Certificate of Free Sale, in this short article we will attempt to shine a light on this process.

Each member state of the EU has a Competent Authority (CA), and it is the member state where your EU Authorised Representative is located that determines the issuing CA. Advena are based in two EU locations the UK and Malta, therefore we can obtain a CFS from the MHRA or the MCCAA.

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 with the EU/EEA.

There are many non-EU/EEA countries who require as supporting documents for local market authorisation a CFS issued by a Competent Authority. Advena when appointed as a manufacturers EC Rep are 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 countries Embassy/Consulate, again Advena are able to facilitate this requirement.

For further information please contact our administration team at info@advenamedical.com

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