Certificates of Free Sale for medical devices are issued by a European Competent Authority, upon request by a manufacturer or an authorised representative. These Certificates verify that a medical device may be legally marketed in Malta and in the European.
Legislation
Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations
Information
Information on Application Form for Certificates of Free Sale (CFS) for Medical Devices.
Application
Application form for Application Form for Certificates of Free Sale (CFS) for Medical Devices.
Competent Authority
Medicines Authority
last updated June 2026
