Export medical devices: special rules
Outside the EU, manufacturers may need a Certificate of Free Sale (CFS) to export medical devices.
8th November 2016
Under the 'Certificate of Free Sale' (CFS) scheme implemented by MHRA, both general devices (like stethoscopes or prescription glasses) and specialist devices (for example, devices that are implantable or used to test samples like calibrators) may be exported to countries outside European Union.
Applicants are requested to check with the destination country to find out if they need a certificate.
A CFS is not required to move medical devices within the EU.
To obtain a CFS from MHRA:
The manufacturer, legal manufacturer, authorised representative or distributor must be based in the UK and the medical devices that are being exported must have both:
a proof of manufacture
a CE marking
Please submit your enquiry via firstname.lastname@example.org if you wish to receive more information regarding CFS.