Free Sale Certificate

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

• CE Certificate(s)
• EU Declaration of Conformity, signed, dated, and stamped
• EU Representative designation letter

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:

• Prepare the Technical File.
• Apply for NB CE Certification or prepare DOC for Class I devices.
• Appoint a European Authorized Representative.
• Register the Medical Devices with the EU.
• Apply for the FSC with the medical device authority where the European Authorized Representative is located.

The timeline for issuing the European Free Sale Certificate is as follows:

• Drafting and mutual signing of the EAR Agreement: 1 week
• EU Registration: 1 week
• FSC Application with Competent Authority: 2-3 weeks
• Issuance of FSC and attestation: 1 week
• Embassy attestation (if required): 1 month (duration varies by country)

We offer fast and cost-effective services for non-European medical device manufacturers and exporters.

• EU Device Registration: 500 Euros per device
• FSC Application and Follow-up: 4500 Euros for up to 2 devices
• FSC Attestation: 350 Euros per UMDNS Code
• Embassy attestation: Please contact us for further information.