Export medical devices: special rules
Check if you need a certificate to export medical devices.
Outside the EU, you may need a Certificate of Free Sale (CFS) to export medical devices.
This includes both general devices (like stethoscopes or prescription glasses) and specialist devices (for example, devices that are implantable or used to test samples like calibrators).
Check with the destination country to find out if you need a certificate. You can also talk to your importer or get help researching your export market.
You don’t need a certificate to move medical devices within the EU.
Before you apply
The manufacturer, legal manufacturer, authorised representative or distributor must be based in the UK and the medical devices you’re exporting must have both:
- a proof of manufacture
- a CE marking
If the device isn’t 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.
How to apply
Register for an account.
You can then log in to apply for a CFS.
Certificates cost £75 per order for the first 10 certificates you buy.
Additional certificates on the same order cost £10 each.
Once you’ve paid, they’ll be posted to you within 5 working days.
Contact the Medicines and Healthcare products Regulatory Agency (MHRA) if you need help.
Published: 7 November 2016