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.

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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.

Compliance Success Stories

Why Obelis?

Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.

Our team regulatory experts will guide you through medical devices’ technical documentation, notification, labelling, among others.

About us
Founded in 1988, we are among Europe’s largest centres for advisory and representative services.
We are certified by ISO 9001:2015 and ISO 13485:2016.
We have helped over 3,000 manufacturers from over 60 countries address their regulatory challenges.
We are members of professional associations and more than 10 European Commission working groups.
Obelis International Offices (OIO) comprise independent partners providing solutions in other global markets.
Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.