For the purpose of exporting to countries outside the European Union (EU) a manufacturer may be asked to provide a Certificate of Free Sale (CFS) as evidence that their devices are CE Marked and available throughout the EU.
There are many non-EU/EEA countries that require, as supporting documents for local market authorisation, a CFS issued by an EU National Competent Authority. Advena, when appointed as a manufacturer’s Authorised Representative (EC REP), is able to provide this important documentation via the Maltese Medicines Authority (MMA), the Competent Authority in Malta.
In many cases, a Certificate of Free Sale must also be apostilled by the Ministry of Foreign Affairs in Malta and then legalised by a country’s Embassy/Consulate and Advena is able to facilitate this requirement. For countries that have signed up to the Hague Convention abolishing the requirement of legalised documents, a CFS will only be required to be apostilled by the Ministry of Foreign Affairs in Malta.
With the introduction of regulations (EU) 2017/745 (MDR) & (EU) 2017/746 (IVDR) CFS’s are applied for and issued in accordance with Article 60 of the MDR & Article 55 of the IVDR as applicable to your devices.
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