CFS for Medical Devices: All You Need to Know

Many regulators around the world require that manufacturers have a Certificate of Free Sales in order to export their medical devices. What is a CFS and how can you request one? Here’s a quick overview to help you on your way.

What is a CFS?
A Certificate of Free Sales (also known as a Free Sales Certificate or CFS) is a document which proves that a medical device is registered in the European Union. It contains information about you (the manufacturer), the authorised representative, and the concerned medical device. A CFS can only be used for export outside the European Union.

Why do I need a CFS?
A CFS is often requested by companies based outside of the European Union. For them, the CFS is proof that your device meets the European CE marking requirements.

Can I request a CFS myself?
If you are a manufacturer based in the European Union, you can apply for a CFS yourself at the ministry of the country where your company is based. If you are established outside of the EU, you can hire an authorised representative to apply for a CFS on your behalf. 

How can we help?
If your company is based outside of the EU, we can request a CFS as your authorised representative. Here’s a step-by-step overview of how we would help you obtain your Certificate of Free Sales:

  • Draw up an authorised representative agreement
  • Carry out a technical documentation review
  • Registration of the medical device with the competent authority (when the medical device is a class I device)
  • Apply for the Certificate of Free Sales with the competent authority
  • When required, ensure the Certificate of Free Sales is legalized or is provided with apostille

More questions?
We are here to help. Get started today with obtaining your CFS or read more about CE marking medical devices here

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Powered by Certification Experts, AR Experts has over 25 years of experience acting as an Authorised Representative to an international customer base. With an in-depth knowledge of the technical and legal aspects of AR, we are a reliable point of contact for market surveillance authorities and potential product controls.

  • Certification Simplified

Powered by Certification Experts, AR Experts has over 25 years of experience acting as an Authorised Representative to an international customer base. With an in-depth knowledge of the technical and legal aspects of AR, we are a reliable point of contact for market surveillance authorities and potential product controls.

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