Guidance

Export medical devices

Check if you need a certificate of free sale to export medical devices outside the EU.

You don’t need a certificate of free sale to move medical devices within the EU.

Outside the EU, you may need a Certificate of Free Sale (CFS) to export medical devices.

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.

Before you apply

The manufacturer, legal manufacturer, or authorised representative must be based in the UK and the medical devices you’re exporting must be CE marked to show compliance with the Medical Device Regulations.

How to apply

Apply for an account.

Once your account has been approved we will email you instructions on how to use the system to purchase certificates of free sale for the medical devices you intend to export.

Already have an account?

If your account was activated before 01 November 2018 please log in to apply for a CFS.

If your account was activated after 01 November 2018 please log in to apply for a CFS.

Fees

Certificates cost £75 per order for the first 10 certificates.

Additional certificates on the same order cost £10 each.

How long will my order take?

CFS for medical devices are issued as pdf documents with electronic signature. Hard copies with wet signature are no longer issued. We will try to process your order within 10 working days from date of receipt. During busy periods orders may take longer. Please order as far in advance as possible.

Please note that the Foreign, Commonwealth & Development Office will not apostille pdf documents directly from us. You will need a Notary who will carry out checks on the certificates with the MHRA to ascertain their authenticity, and can then notarise the certificates, if required by the recipient country. Once notarised, the Foreign, Commonwealth & Development Office will apostille the documents.

Getting help

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

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

Published 7 November 2016
Last updated 27 November 2018 + show all updates
  1. Updated all the information on page with updated links etc

  2. First published.