Free Sales Certificate / Certificate of Marketability
Have MDSS, your Authorized Representative (AR), apply for a Free Sales Certificate/Certificate of Marketability on your behalf
From the regulatory point of view, the requirements for the introduction
of a medical device on the European market are fulfilled. 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 (precisely the
EU, EEA and the few other countries having mutual recognition
agreements in place).
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
In order to obtain a Free Sales Certificate / Certificate of Marketability for MDD and IVD devices the following information are needed:
MDSS as your Authorized Representative may obtain a Free Sales
Certificate for any non European country. MDSS currently implemented a
fast process for the following countries:
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
Medical Device Safety Service GmbH
Phone: +49 511 6262 8630
Fax: +49 511 6262 8633
Or Click here for Contact Form
If MDSS is not currently your Authorized Representative we offer the
service of further legalization through consulates as well. Please
contact us directly in this case.