Free Sales Certificate / Certificate of Marketability
Have MDSS, your Authorized Representative (AR), apply for a Free Sales Certificate/Certificate of Marketability on your behalf
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
Algeria, Argentina, Bolivia, Brazil, Cambodia, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Guatemala, Hong Kong, India, Indonesia, Iran, Israel, Jordan, Kazakhstan, Morocco, Mexico, Nigeria, Panama, Paraguay, Peru, Philippines, Russia, Saudi Arabia, Serbia, Singapore, South Korea, Sri Lanka, Syria, Taiwan, Thailand, United Arab Emirates, Uruguay, Venezuela and Vietnam.
The identification of the country is important because often the certificate of Marketability has been issued by the Authority and various different requirements are imposed by the country in regards to the legalization (apostille, translation, certification by the consulate etc.)
MDSS is the expert on all the various steps which need to be applied. If you would like to apply for a Free Sales Certificate for a country not listed above let us know and we will find out the requirements for it.
Medical Device Safety Service GmbH
Phone: +49 511 6262 8630
Fax: +49 511 6262 8633
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