CertificateExport of Free Sale for exporting medical devices

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.

WeThe MHRA only issueissues a CFS foras a service to UK exporters for medical devices. If you need a CFS for other productsproducts, you should contact the Department for Business and Trade (DBT).

Before you apply

A CFS can only be ordered for medical devices and IVDs that have been registered throughwith the MHRA on 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 responsibleResponsible personPerson or Northern Ireland-based authorisedAuthorised representative.Representative. You will have to provide evidence that the medical devices you are exporting have relevant conformity assessment marks (UKCA, CECE, or CE UKNI) to show youcompliance are complying with the UK Medical Devices Regulations 2002 (as amended). that enable them to be placed on the UK market.

Certificates of Free Sale

A CFS should not be taken as a governmentGovernment 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. YouPlease cansee find out more in The Russia Sanctions Regulations 2022 and Consolidated list of strategic military and dual-use items that require export authorisation.

InDepending on where the manufacturer, UK Responsible Person or Authorised Representative is based, and the mark of conformity, we will issue a different CFS.

For the purposes of 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 provideapostille 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 approveapostille the documents.

How to apply

Apply for an account with the MHRA.

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.

Fees

SeeCertificates Currentcost MHRA£75 fees:per Medicalorder Devices for further information on fees for Certificatesthe offirst Free10 Sale for medical devices.certificates.

EnsureAdditional thatcertificates paymentson forthe Certificatessame oforder Freecost Sale£10 areeach.

How onlylong madewill throughmy the Deviceorder Online Registration System (DORS).take?

OrderHow timescaleslong will my order take?

We will try to process your order within 10 working days from date of receipt. During busy periods,periods orders may take longer.

Please order as far in advance as possible.

Reference guide

Certificates of Free Sale Reference Guide AprilMarch 20262025 (PDF, 1.621.47 MB, 3433 pages)

Video tutorial

How to order and reorder Certificates of Free Sale

YouContact canthe contactMedicines usand 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