Application Form for Organisation Registration in relation to Medical Devices

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)

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Application

Application form for Changes to Labelling and Package Leaflets in Accordance with Article 61(3).

Competent Authority

Medicines Authority

 

 

 

 

 

 

 

last updated June 2026

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