Free Sales Certificates (FSC)
A Free Trade Certificate, or Free Sales Certificate, is a certificate issued by EU competent authorities to facilitate market entry into other markets worldwide.
Compliance with the EU requirements often grants access to many other countries outside the EU. Non-EU manufacturers of medical devices and IVD medical devices can request through their authorised representative a Free Sales Certificate (FSC). Obelis acts as your authorised representative and applies for FSCs worldwide. If you are an EU-based manufacturer, Obelis can apply for an FSC and assist you with our consultancy services.
The Representative of choice for
The main requirement to apply for an FSC is compliance with the EU regulations. If you want to apply for an FSC, Obelis will:
- Acts as your authorised representative or regulatory consultant
- Check that you are compliant with the EU Medical Devices Regulation or IVD Medical Devices Regulation (MDR and IVDR). Legacy devices can also apply for an FSC if compliant.
- Collect the necessary document for the FSC application
- Apply for the FSC
- Provide manufacturers with the FSC ready to be used with non-EU competent authorities
It is crucial that the non-EU manufacturer must have appointed a European Authorised Representative. This is a mandatory requirement by law if your business address is located outside of the EU and EEA.
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”