Medicines, medical devices and blood regulation and safety – news story

Certificates of Free Sale for medical devices: update

From 1 April 2015, MHRA will be issuing Certificates of Free Sale for medical devices.

Below is information about the transfer of the service from the Department of Health (DH) to the Medicines and Healthcare products Regulatory Agency (MHRA).

MHRA has invested in a newly-built web based Certificate of Free Sale (CFS) system and all submissions will have to be made using this system. We will no longer accept paper applications. There will be no pre-loaded information on the system.

The DH archive will be transferred to MHRA to allow users to have access to this information however this will not be available immediately.

Users will need to register with the new web-based system and will then add details of the devices for which they are requesting certificates. MHRA will then check and verify the request and issue the certificates if the information is approved.

The certificates will be printed on MHRA-embossed paper and posted to CFS users. Users will be able to add more than one address for the certificates to be sent to.

MHRA will be charging a small fee and we will only accept payment for the fee by debit and credit card. We will send out a receipt with the signed paper certificate.

A link to the system and information about using it will be available on GOV.UK.

We will be organising training on the new system, which is likely to be via a webinar.

If you would like to take part in the training please email cfs@mhra.gsi.gov.uk.

As the system is new, we are asking users to submit requests for certificates as they are needed rather than in bulk.

If you know you will be submitting requests in the first month could you let us know by emailing cfs@mhra.gsi.gov.uk.