Certificates of Free Sale for medical devices: registration and use
How to register for a Certificate of Free Sale (CFS)
Certificates of Free Sale are documents used in the registration or renewal of the registration, of medical devices in non-EU countries (ie countries outside the European Economic Area) or to accompany a shipment of that device.
Get a Certificate of Free Sale
You can submit requests for a Certificate of Free Sale for export purposes for:
- general medical device(s)
- active implantable medical device(s)
- in-vitro diagnostic medical device(s)
- mixture of the above devices
You will need to provide different types of certification by a notified body depending on the class of the device you you need the CFS for. Each certificate is issued for a specific device or a group of devices.
The content of the certificate will depend on:
- whether the devices are CE marked or non-CE marked
- the directives covering the different classes of devices
We can only issue a certificate of free sale if:
- we are given proof of manufacture for the relevant devices
- the manufacturer is certified to manufacture products with a CE mark, where applicable
- the manufacturer, authorised representative or legal manufacturer is located in the UK
If the device is non-CE marked for the purpose of being sold outside the EU, the manufacturer must prove that the device is equivalent to one that is CE marked.
Certificate of Free Sale - user manual (PDF, 3.76MB, 81 pages)
Certificate of Free Sale - using schedules (PDF, 912KB, 19 pages)
Email firstname.lastname@example.org, telephone 020 3080 7171
Published: 1 April 2015