Guidance

Export medical devices

Order a certificate of free sale to export medical devices outside the UK.

From:
Medicines and Healthcare products Regulatory Agency
Published
7 November 2016
Last updated
2 August 2024 — See all updates

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.

The MHRA only issues a CFS as a service to UK exporters for medical devices. If you need a CFS for other products, 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 with 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 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, CE UKNI) to show compliance 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 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. Please see The Russia Sanctions Regulations 2022 and Consolidated list of strategic military and dual-use items that require export authorisation.

Depending 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 & 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.

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

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 for Medical Devices (PDF, 1.47 MB, 33 pages)

Video tutorial

How to order and reorder Certificates of Free Sale

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

Updates to this page

Published 7 November 2016
Last updated 2 August 2024 + show all updates

  1. Updated 'Certificates of Free Sale for Medical Devices' to reflect changes to the registration and Certificates of Free Sale system.

  2. Updated 'Certificates of Free Sale Reference Guide'

  3. Updated 'Certificates of Free Sale for Medical Devices' reference guide.

  4. Updated video tutorial for 'How to order and reorder Certificates of Free Sale'

  5. Updated file 'Certificates of Free Sale for Medical Devices'.

  6. Updated 'Certificates of Free Sale for Medical Devices' PDF.

  7. Extra paragraph added to 'Certificates of free sale' section: '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. Please see The Russia Sanctions Regulations 2022 and Consolidated list of strategic military and dual-use items that require export authorisation.'

  8. Updated Certificates of Free Sale Reference Guide and How to order and reorder Certificates of Free Sale video tutorial

  9. Updated the Certificates of Free Sale Reference Guide

  10. The reference guides and attributes list have been updated and new and updated videos have been created.

  11. Updated Certificate of Free Sale Reference Guide

  12. Updated due to the end of the Brexit transition period.

  13. Updated all the information on page with updated links etc

  14. First published.

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Contents

Part of Export goods from the UK: step by step

  1. Step 1 Check if you need to follow this process

    Follow these steps if you're moving goods permanently from:

    • England, Wales or Scotland (Great Britain) to a country outside the UK
    • Northern Ireland to a country outside the UK and the EU

    What you need to do is different if you are:

    1. Learn about exporting, including making export plans, on great.gov.uk

  2. Step 2 Check the rules for exporting your goods

    1. Check duties, rules and restrictions for your goods in the destination country

  3. and Apply for any licences you need to export your goods

    There are special rules and you may need to get licences or certificates if you are exporting any of the following:

  4. Step 3 Get your business ready to export

    You need an EORI number that starts with GB to export goods from England, Wales or Scotland.

    If you move goods to or from Northern Ireland you may need one that starts with XI.

    1. Get an EORI number
    1. Check if you need to register for VAT

    There are processes that can make clearing customs quicker and easier to manage if you export goods regularly.

    1. Find out about using simplified declaration procedures
    2. Check if you can use Common Transit to move your goods
    3. Check if Authorised Economic Operator status is right for you

  5. and Check whoever's receiving the goods can import them

    The business or person receiving the goods may need:

    • to make an import declaration in their country
    • licences or certificates to receive goods from the UK

    Check whoever you are sending the goods to is able to import them into their country.

  6. Step 4 Decide who will make export declarations and transport the goods

    You can hire someone to deal with customs and transport the goods for you, or you can do it yourself.

    1. Find out how to hire someone to deal with customs for you
    2. Find out how to make export declarations yourself
    3. Find out how to transport goods out of the UK by road

  7. Step 5 Classify your goods

    You must find the right commodity code to classify the goods you're exporting.

    Your customs agent or transporter might be able to help you with this.

    1. Find the right commodity code for your goods

  8. Step 6 Prepare the invoice and other documentation for your goods

    The completed invoice and any licences or certificates must travel with the goods.

    When filling in the value of your goods on the invoice, use the price you’re selling them for. If you're not selling the goods, use the market value of the goods. List any freight or export insurance you included in the price separately.

    You may need proof of origin if exporting to a country where your goods have a reduced or zero rate of duty.

    1. Get proof of origin for your goods

    You might be able to zero rate the goods for VAT. This means you can charge your customers VAT at 0%.

    1. Check if you can zero rate the goods for VAT

  9. Step 7 Get your goods through customs

    If you've appointed someone to deal with UK customs for you, they'll make the declaration and get your goods through the UK border.

    1. Make an export declaration and get your goods cleared by UK customs

    You may need other documentation to get your goods into the destination country. Ask the person or business buying your goods what information you need to provide.

    1. Check how to bring goods back into the UK if they were rejected for import at another country’s border

  10. Step 8 Keep invoices and records

    You must keep commercial invoices and any customs paperwork.

    If you're VAT registered, record the goods in your VAT accounts even if they are zero-rated.

    1. Find out how to record the goods in your VAT accounts

    If you exported controlled goods, for example firearms, keep the paperwork that shows who owns the goods.