Certificates of free sale

This page is for device industry.

It provides information about certificates of free sale for medical devices.  It describes what they are and how to apply for one.

What is a certificate of free sale?

A certificate of free sale is a document used in the registration of a device in a third country (i.e. countries outside the EU). It indicates that a device is compliant with EU law.

How do I get a certificate of free sale?

If you are a manufacturer or authorised representative based in Ireland and would like to obtain a certificate of free sale, you must submit a certificate of free sale application form and a device schedule to us via our online contact form. Please select Medical devices > Certificates of free sale in the drop-down menus. Both of these forms are linked below.

A certificate of free sale checklist is included in the application form to help you prepare your application.