Free Sales Cert(FSC)/Certificate of Marketability(CoM)
From the regulatory point of view, the requirements for the introduction of a medical device on the European market are fulfilled. The CE mark is an indication to show conformity to all obligations for medical devices as required by the Medical Devices Directives. With the CE mark in place your products can be legally marketed in Europe (precisely the EU, EEA and the few other countries having mutual recognition agreements in place).
However, for the penetration to non-EU markets a Free Sales Certificate must be provided by the manufacturer. The Free Sales Certificate demonstrates from the government that you place products, legally with the CE mark on the European market.
The European Free Sales Certificate (FSC) / Certificate of Marketability, is issued by the Competent Authority of the EU member state where the “manufacturer” in Europe or his authorized representative (EC REP) has his registered place of business. If the manufacturer is not situated in Europe only the Authorized Representative is able to obtain the Free Sales Certificate on behalf of the manufacturer.
In order to obtain a Free Sales Certificate / Certificate of Marketability for MDD and IVD devices the following information are needed:
Product names and/or model/part numbers
The country you would like to apply for a Free Sales Certificate / Certificate of Marketability
What is the difference between FSC and CoM?
There is a confusion between FSC and CoM
This confusion occurs in countries that do not use English as the national language. However, the only difference between the two documents is the difference in translation.
Certain regions use administrative forms English-translated as Free Sales Certificates, while other regions use forms translated as Certificate of Marketability.
To mitigate this confusion, it is necessary to fully explain to the requestor of the document that the two documents are the same document issued by the same act and the only difference is the English translation.
Wise Co., Inc. can help you with issuing Certifiate of Marketability.
Please Contact us for any further question.