FREE SALES CERTIFICATE
MDSS GmbH, your Authorized Representative (EC REP), offers support during the whole process of applying for a Free Sales Certificate (FSC) / Certificate of Free Sale (CFS) / Certificate of Marketability for non-European countries.
FAST PROCESS FOR OVER 60 COUNTRIES
Algeria
Argentina
Bangladesh
Belarus
Bolivia
Bosnia and Herzegovina
Brazil
Cambodia
Cameroon
Chile
China
Colombia
Costa Rica
Cuba
Ecuador
Egypt
Ethiopia
Georgia
Ghana
Guatemala
Honduras
Hong Kong
India
Indonesia
Iran
Iraq
Israel
Jamaica
Jordan
Kazakhstan
Kuwait
Lebanon
Madagascar
Malaysia
Mexico
Montenegro
Morocco
Nicaragua
Nigeria
Pakistan
Panama
Paraguay
Peru
Philippines
Russia
Saudi Arabia
Serbia
Singapore
South Korea
Sri Lanka
Sudan
Syrian
Taiwan
Thailand
Tunisia
Ukraine
United Arab Emirates
Uruguay
Venezuela
Vietnam.
If you would like to apply for a FSC / CFS for a country not listed above let us know and we will find out the requirements for it.
FSC Process
With the CE mark in place your products can be legally marketed in Europe. The CE mark is an indication to show conformity to all obligations for medical devices, as required by the Medical Devices Regulations.
However, for entering certain non-EU markets a FSC / CFS must be provided by the manufacturer. It demonstrates, from the government point of view, that you place your products legally, with the CE mark, on the European market.
The European FSC / CFS, is issued by the Competent Authority of the EU member state where the “manufacturer” or his EC REP has his registered place of business. If the manufacturer is not situated in Europe only the EC REP is able to obtain the FSC /CFS on behalf of the manufacturer.
Additional Services
GMDN Code Research
VIGILANCE
NATIONAL REGISTRATIONS
