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News and Views June 2011: Free Sales Certificate


Free Sales Certificates (FSC):

A number of clients are very familiar with the FSC, others may not.  A reason to outline this within this News and Views.  The FSC is a document issued by the Authority responsible for the AR or the manufacturer.  The FSC may be used in other countries to market products in those countries (e.g. countries in South America or Asia).  With the CE mark and the FSC the market entry seems much easier.  Please inquire with your local contact in those countries and ask them whether the FSC may be useful. 

 

The FSC confirms that the medical devices are being freely marketed in the European Union.  Additional assurances for those countries beside the CE mark certificates.  The FSC may need to be notarized or other steps are involved to achieve valid documents.  Due to that reason it is necessary to issue those documents specific to a country. 

 

MDSS service for free sales certificates:

MDSS has now explored a number of countries and acquired the knowledge to have the FSC issued quickly by the authority and to perform all steps that the FSCs are being accepted within the particular countries.  Please contact us. 


Please visit our website for further information


The Team of MDSS


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