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.
MDSS currently implemented a fast process for the following countries:
Algeria, Argentina, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Cameroon, Chile, China, Colombia, Costa Rica, Cuba, Ecuador, Egypt, El Salvador , Ethiopia , Georgia, Ghana, Guatemala, Honduras, Hong Kong , India, Indonesia, Iran , Iraq, Israel, Jamaica, Jordan, Kazakhstan, Kuwait, Lebanon, Macedonia, Madagascar , Malaysia, Mexico, Montenegro , Morocco, Nicaragua, Nigeria, Pakistan, Panama, Paraguay , Peru, Philippines, Russia, Saudi Arabia, Serbia, Singapore, South Africa, 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.
The identification of the country is crucial because, once the FSC / CFS has been issued by the Authority, different requirements are imposed by the country in regards to the legalization (apostille, translation, authentication by the consulate etc.).
If MDSS is not currently your Authorized Representative (EC REP) we offer the service of further legalization through consulates as well.