The Application is being presented by the Malta Medicines Authority to increase functionality at all regulatory levels and to allow better communication between the competent Authority and the Distributors, Importers, Manufacturers, Authorised Representatives and Notified Bodies.
Legislation
Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations
Information
Information on Changes to Labelling and Package Leaflets in Accordance with Article 61(3)
.
Application
Application form for Changes to Labelling and Package Leaflets in Accordance with Article 61(3).
Competent Authority
Medicines Authority
last updated June 2026
