Certificate of Free Sale for exporting medical devices
Source: gov.uk (2025-03-13)

How to apply for a certificate of free sale to export medical devices outside the UK.

You may need a Certificate of Free Sale (CFS) to export medical devices.

To find out, check the import rules of the country you are exporting to.

Talk to your importer or get help researching your export market (https://www.gov.uk/government/collections/exporting-country-guides).

We only issue a CFS for UK exporters for medical devices. If you need a CFS for other products you should contact the Department for Business and Trade (DBT) (https://www.gov.uk/government/organisations/department-for-business-and-trade).

Before you apply

A CFS can only be ordered for medical devices and IVDs that have been registered through our Device Online Registration System (DORS). In vitro diagnostic medical devices for performance evaluation cannot be included on CFS orders.

A CFS can only be ordered by a UK-based manufacturer, UK responsible person or Northern Ireland-based authorised representative. You will have to provide evidence that the medical devices you are exporting have relevant conformity assessment marks (UKCA, CE or CE UKNI) to show you are complying with the UK Medical Devices Regulations 2002 (as amended) (https://www.legislation.gov.uk/uksi/2002/618/contents/made).

Certificates of Free Sale

A CFS should not be taken as a government endorsement of any product that is referred to on the certificate.

In issuing a CFS, the MHRA does not assess or verify that the product complies with relevant export requirements and restrictions. It is the applicant’s responsibility to ensure compliance with these requirements and restrictions. You can find out more in The Russia Sanctions Regulations 2022 (https://www.legislation.gov.uk/uksi/2022/195/pdfs/uksi_20220195_en.pdf) and Consolidated list of strategic military and dual-use items that require export authorisation (https://www.gov.uk/government/publications/uk-strategic-export-control-lists-the-consolidated-list-of-strategic-military-and-dual-use-items-that-require-export-authorisation).

In Great Britain (England, Wales and Scotland), we will issue a CFS for the UKCA mark stating that the medical device can be freely sold on the Great Britain market.

If you are a Northern Ireland manufacturer or Northern Ireland-based Authorised Representative we will issue a CFS for CE marked devices, that states they can be sold freely in the UK and EEA. If the device is CE UKNI marked, the CFS will state that the device can be freely sold in the UK only.

These MHRA certificates are issued as PDF documents with an electronic signature.

Please note that the Foreign, Commonwealth and Development Office will not provide authentication for 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 approve the documents.

How to apply

Apply for an account with the MHRA (https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration).

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

Already have an account?

If you already have devices registered with the MHRA for CFS purposes you will need to confirm the accuracy of the registered information on the Device Online Registration System (DORS) or re-register your details and devices according to the grace periods set out in our registration guidance (https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market).

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?

How long will my order take?

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.

Reference guide

Certificates of Free Sale Reference Guide March 2025 (https://assets.publishing.service.gov.uk/media/67c9b8188247839c255ae3d6/Certificates_of_Free_Sale_Reference_Guide_March_2025_Final_v1.pdf) (PDF, 1.47 MB, 33 pages)

Video tutorial

How to order and reorder Certificates of Free Sale (https://mhra-gov.filecamp.com/s/i/jKrZFC5aDeOLsbWG)

You can contact us if you need help.

MHRA CFS team xxx@xxx.xx (mailto:xxx@xxx.xx) Telephone: xx-xxxx-xxxx Monday to Friday, 9am to 5pm Find out about call charges (http://www.gov.uk/call-charges)