MT-MDF03 - Application Form for Medical Device Registration to place Medical Devices on the EU Market

Last Updated: Tuesday 16 June 2026

Overview

A manufacturer or authorised representative may submit an application with the Malta Medicines Authority to place a Medical Device onto the European Market.

What you'll get

Medical Device Registration Letter issued by the Malta Medicines Authority.

Eligibility

Manufacturers, Authorised Representatives.

How to apply

Fill in and Submit the online form.

Fast Track Option (10 days) available for this Application

Timeline

Submission of Application

Standard Service

30 days

Submit your application

Apply