11/04/2015

Obelis SA Obelis European Authorized Representative Center

Reference countries for Free Sales Certificate

A Free Sales Certificate (FSC) also referred to as “Free Trade Certificate” or “Certificate for Export” is an international export document. The certificate is intended to serve as evidence that the goods (medical devices, cosmetics, pharmaceuticals, etc.) meet the health and safety requirements of the exporting market and can therefore be made available on the importing market.


Reference countries


Of course, countries and their respective markets differ in size, purchasing power or viability. Therefore, the Free Sales Certificate is perceived differently depending on its issuing authority. While the majority of national legislations make no suggestions that certain certificates are accepted and others are not, it has become well known that the certificates issued by certain “reference countries” have a higher acceptance rate.


The most common ‘reference countries’ are:
•Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Spain, Sweden and the UK;
•Iceland, Norway & Switzerland;
•Australia, New Zealand, Japan, Canada & the USA;


An example for such a requirement comes from Egypt, where both the Central Administration for Pharmaceutical Affairs (CAPA) and Egypt’s International Trade Administration have published a list of reference countries that companies seeking to place their products on the Egyptian market should use as guidance in order to ease their market access.


FSC application


In order to obtain a Free Sales Certificate for medical devices (under either the MDD 93/42/EEC, AIMDD 90/385/EEC or the IVDD 98/79/EC) from a European Authority, two pre-requisites must be met:
1.The device must bear the CE Marking
2.The manufacturer (brand owner), if established outside the European Union, must appoint a European Authorized Representative


As a professional European Authorized Representative, Obelis provides Non-EU manufacturers with Free Sales Certificate application services through the Belgian Ministry.


If you would like to know more on how to obtain a Free Sales Certificate, please contact us.