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Home / Medical Devices

Medical Devices

In line with Legal Notices 318-321 published in the National Gazette on 4th August 2020; the Malta Medicines Authority has been appointed as the National Competent Authority for Medical Devices.

The regulatory role of the Medical Device Unit in the Malta Medicines Authority is to manage the operations as the Maltese National Competent Authority for medical devices. This includes the monitoring of all medical devices placed on the local market, while making sure that they are safe for the public and that they function as intended.

The Medical Device Unit, through a national centralised management system, carries out registration of local Economic Operators, the listing of medical devices placed on the local market and a reporting system for medical device incident reports. Site audits and inspections of local medical device economic operators are carried out to ensure compliance with the relevant European and local legislation and standards. A role of the Medical Device Unit is to designate and continuously monitor the performance of Notified Bodies registered in Malta. The Medical Device Unit is also an active member of EU Committees and Medical Device Coordination Groups.

 

Medical Device News 

For news bulletins and circulars in relation to medical devices please click <here>.

 

Medical Device Legislation

For a list of all current medical device legislation please click <here>.

 

Medical Device Forms 

For a list of all current medical device forms click <here>.

 

Medical Device Local Guidelines

For a list of all current medical device legislation please click <here>.

 

Medical Device Field Safety Notice

For a list of medial device field safety notices please click <here>.

 

Information on Medical Devices

For information on medical devices click <here>.

 

Medical Device Unit Contact Details

Email: devices.medicinesauthority@gov.mt