Complementary service to the EC REP mandate
Free Sale Certificate (FSC) for medical devices
Certificat de Libre Vente (CLV)
The Free Sale Certificate (FSC), known in France as the Certificat de Libre Vente (CLV), is required by approximately one hundred countries to register a medical device on their local market. It certifies that the device is legally marketed in the European Union and that no restrictive measure has been taken by the competent authority.
In France, this document is issued exclusively by the CCI Paris Île-de-France since 2015 — not by the ANSM.
When do you need it?
Any manufacturer exporting devices to North Africa, the Middle East, Africa, Latin America, or Asia encounters this requirement from the first local registration application. The FSC is not optional: without it, the registration file is not admissible.
It covers medical devices (MDR 2017/745), in vitro diagnostic devices (IVDR 2017/746), and active implantable medical devices.
The French advantage: 10 originals for the price of one
In Belgium, each FSC application produces one original, with a limit of 10 devices per certificate. In France, a single FSC entitles the manufacturer to 10 identical originals and can cover several hundred references in the annex.
For a manufacturer exporting to five countries simultaneously with a catalogue of 30 references: one file, one CCI fee, ten originals available.
This is why appointing an EC REP established in France changes the calculation for non-EU manufacturers with high export volumes.
originals
per FSC file
France-only
advantage
What ISOFAC GROUP handles
An incomplete FSC file is returned without processing. A misdirected file — wrong template, non-compliant annex, insufficient supporting documents — results in an additional 15-day delay before re-examination.
ISOFAC GROUP assembles the complete file from the first submission:
- Eligibility check and document consistency review (DoC, CE certificate, UDI)
- Selection of the applicable bilingual template (MDR 2017/745, IVDR 2017/746, AIMD)
- Preparation of the product annex and tracked postal submission
- Forwarding of signed originals upon receipt
Pricing
| Service | Turnaround | Price (excl. VAT) |
|---|---|---|
| Standard FSC | ~15 days | €450 |
| Express FSC | ~8 days | €650 |
| Urgent FSC | ~5 days | €850 |
| Pack 5 FSC / year | Standard | €2,000 |
| Pack 10 FSC / year | Standard | €3,800 |
Additional options on request: Court of Appeal apostille, consular legalisation, large annex (more than 100 references).
FSC and EC REP mandate: a direct link
The European Authorised Representative is the natural point of contact for obtaining an FSC on behalf of the non-EU manufacturer. As EC REP, ISOFAC GROUP has direct access to the technical documentation and the regulatory standing to assemble the file without any additional intermediary.
ISOFAC GROUP EC REP clients benefit from preferential conditions on FSCs, as specified in the mandate proposal.
Obtain an FSC for my devices
An initial call allows us to qualify your request and define the scope of involvement.