CERTIFICATE OF FREE SALE
MEDIACAL DEVICE CERTIFICATE OF FREE SALE
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.
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
-
Aemi World as your Authorized Representative may obtain a Free Sales Certificate
for any non European country.