A Free Sales Certificate (FSC) is an essential document for medical device and in vitro diagnostic (IVD) manufacturers seeking to export their products outside the European Union (EU). At EUmAccess GmbH, we assist manufacturers in obtaining FSCs from the relevant EU Competent Authorities, ensuring smooth international trade and regulatory compliance.
What is a Free Sales Certificate (FSC)?
A Free Sales Certificate (FSC) is an official document issued by an EU Competent Authority confirming that:
- The medical device or IVD is CE-marked and compliant with MDR (2017/745) or IVDR (2017/746)
- The product is legally marketed within the EU/EEA
- The manufacturer has met all regulatory and safety requirements
Many non-EU countries require an FSC as part of the registration process before allowing medical devices into their markets.
Who Can Apply for an FSC?
EU Manufacturers
Can apply directly to their national Competent Authority
Non-EU Manufacturers
Must apply through their EU Authorised Representative (E.A.R.)
Importers & Distributors
May need FSCs for regulatory approval in target countries
Our EUDAMED Registration Services
FSC Application Support
We assist in preparing and submitting applications to the relevant EU Competent Authorities
Document Preparation & Review
Ensuring your CE Marking, Declaration of Conformity (DoC), and Technical File meet requirements
Coordination with Competent Authorities
Managing the communication with health authorities for a smooth approval process
FSC Renewal & Updates
Assisting with renewals or modifications based on regulatory changes
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.