Guidance

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

How to apply

Register for an account.

You can then log in to apply for a CFS.

Read the guidance notes on how to apply (PDF, 3.76MB, 81 pages) and using schedules (PDF, 912KB, 19 pages) .

Fees

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.

Getting help

Contact the Medicines and Healthcare products Regulatory Agency (MHRA) if you need help.

MHRA CFS team
cfs@mhra.gov.uk
Telephone: 020 3080 7171
Monday to Friday, 9am to 5pm
Find out about call charges

Published 7 November 2016