Certificate of Free Sales for Medical Devices: All You Need to Know

What is a Certificate of Free Sales?

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 EC Rep (Authorised Representative for medical devices), and the concerned medical device. A CFS can only be used for export outside the European Union.

Why do I need a Certificate of Free Sales?

A CFS is often requested by companies based outside of the European Union. For them, the CFS is proof that your medical device meets the European CE marking requirements.

Can I request a Certificate of Free Sales myself?

If you are a manufacturer based in the European Union, you can apply for a CFS for your medical devices 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 Free Sales Certificate as your EC Rep (EU Authorised Representative for Medical Devices CE marking). Here’s a step-by-step overview of how we would help you obtain your Free Sales Certificate for your medical devices:

• Draw up an EC Rep Mandate (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 Free Sales Certificate for medical devices with the competent authority
• When required, ensure the Free Sales Certificate for you medical device is legalized or is provided with apostille

More questions?

We are here to help. Contact us today with obtaining your CFS for your medical device. You can also read more about CE marking medical devices here. Of you can read more about GMP in medical or how things are handled with the NMPA for China.