Usually 6-8 Working Days
Welcome to our website. We at Cert3Global offer a European Free Sale Certificate (FSC) service for non-European manufacturers who require EU representation for MDR & IVDR.
To apply for a European Free Sale Certificate and initiate the FSC process, choose the desired service and fill out the below form.
To apply for a European Free Sale Certificate and initiate the FSC process, choose the desired service and fill out the message form.
The European Free Sale Certificate (FSC) is essential for demonstrating the legal ability to freely sell or distribute medical devices without restrictions, with approval from the country’s regulatory authority.
Any European country can issue the FSC upon request by an Authorized Representative acting on behalf of a foreign medical device manufacturer.
If your company is from a non-European country and cannot communicate directly with the Competent Authority, we can serve as your European Authorized Representative. Contact us for further details.
To obtain the FSC from a European Authority, the following Documentation is required:
EU Registration Details
The FSC can be legalized by the Chamber of Commerce, the Ministry of Foreign Affairs, and the relevant Embassy in EU countries.
Learn more about the EU Registration (EUDAMED) process by visiting our website.
If your medical device is not manufactured in Europe, only an Authorized Representative can obtain the FSC on behalf of the manufacturer.
The process for obtaining the FSC is as follows:
The timeline for issuing the European Free Sale Certificate is as follows:
We offer fast and cost-effective services for non-European medical device manufacturers and exporters.