FREE SALES CERTIFICATE (EU/UK/Switzerland)
The MDSS team can support with a FSC application with the EU, UK and Swiss Authority! |
FAST PROCESS FOR OVER 60 COUNTRIES
| Algeria | Argentina | Albania | Bahrain |
| Bangladesh | Belarus | Bolivia | Bosnia and Herzegovina |
| Brazil | Chile | Colombia | Costa Rica |
| Dominican Republic | Ecuador | Egypt | El Salvador |
| Ethiopia | Georgia | Guatemala | Honduras |
| Hong Kong | India | Indonesia | Iran |
| Iraq | Israel | Jamaica | Japan |
| Jordan | Kazakhstan | Kuwait | Kyrgyzstan |
| Malaysia | Mexico | Montenegro | Myanmar |
| Nicaragua | Nigeria | North Macedonia | Oman |
| Pakistan | Panama | Paraguay | Peru |
| Philippines | Qatar | Russia | Saudi Arabia |
| Serbia | Singapore | South Africa | South Korea |
| Sri Lanka | Taiwan | Thailand | Tunisia |
| Turkey | Ukraine | United Arab Emirates | Uruguay |
| Venezuela | Vietnam |
If you would like to apply for a FSC for a country not listed above let us know and we will find out the requirements for it.
FSC Process
The CE marking is an indication to show conformity to all obligations for medical devices, as required by the Medical Devices Regulations.
However, for entering certain non-European markets a FSC 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 FSC is issued by the Competent Authority of the country where the manufacturer or his EC REP / UKRP / CH-REP has his registered place of business. If the manufacturer is not situated in Europe, only the EC REP / UKRP / CH-REP is able to obtain the FSC on behalf of the manufacturer.
Additional Services
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NATIONAL REGISTRATION | GMDN CODE RESEARCH | VIGILANCE |
UK Responsible Person6 Wilmslow Road, Rusholme, Manchester M14 5TP, UK
+44 7898 375115
