For EU-REP Clients Only
Free Sales Certificate (FSC) Application Service
As part of your EU-REP mandate, we handle the complete FSC application process - from preparation to authority correspondence to certificate delivery.
- Full application handling on your behalf
- Complete authority correspondence
- Available for Medical Devices and IVDs
On this page
What is a Free Sales Certificate?
A Free Sales Certificate (FSC) is an official document issued by a competent authority confirming that a medical device or IVD is legally marketed and freely sold in the issuing country or region.
Many countries outside the EU require an FSC as part of their import or registration process. The FSC serves as evidence that the device meets the regulatory requirements of the EU and is in free circulation on the European market.
Common uses for FSCs:
- Registration of medical devices in non-EU countries
- Import permits and customs clearance
- Tender submissions requiring proof of EU market authorisation
- Regulatory submissions to health authorities worldwide
Service Availability: FSC application services are exclusively available to non-EU manufacturers who have an active EU-REP mandate with MedNet EC-REP.
Service Scope
What this service covers
As your Authorised Representative, we are authorised to apply for Free Sales Certificates on your behalf from the relevant EU competent authorities. This service covers the complete application process, including all correspondence with authorities.
German FSC (BfArM)
Free Sales Certificates issued by the German Federal Institute for Drugs and Medical Devices for devices registered in Germany.
Other EU Member States
FSC applications to competent authorities in other EU member states where your devices are registered, as required.
Multiple Products
FSC applications covering single devices or multiple products, depending on authority requirements and your needs.
Complete application handling
We handle the entire FSC application process on your behalf. You do not need to communicate with EU authorities directly - we manage all correspondence and deliver the final certificate to you.
Our FSC Application Services
We handle:
Application Preparation: We prepare the complete FSC application including all required forms and supporting documentation.
Authority Submission: We submit the application to the relevant competent authority on your behalf.
Correspondence Handling: We manage all communication with the authority, including responding to queries and providing additional information.
Fee Processing: We handle the payment of any authority fees (fees are invoiced to you separately).
Certificate Delivery: We deliver the issued FSC to you, ready for submission to your target market authorities.
What You Provide
Information required from you
To apply for an FSC, we need certain information from you. The exact requirements depend on the issuing authority and the type of certificate requested.
Typical Information Required
You provide:
Product List: The devices for which you need FSCs, including product names, models, and UDI-DIs where applicable.
Target Countries: The countries where you intend to use the FSC, as some authorities require this information.
Certificate Quantity: The number of original certificates required (some authorities charge per copy).
Specific Requirements: Any specific requirements from the target country authority (e.g., apostille, legalisation, specific wording).
We already have access to your technical documentation, CE certificates, and EUDAMED registration data as your EU-REP. You do not need to provide these documents again for FSC applications.
Frequently Asked Questions
Common questions about Free Sales Certificates
Have more questions? Contact our team for clarification.