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Home / Medical Devices

Medical Devices

Fees pertaining to Medical Device Regulatory Procedures have been updated.
Go to Guidance

 

Malta Medicines Authority: Safeguarding Public Health through Medical Devices Regulation

In accordance with Subsidiary Legislation 458.59, Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations, the Malta Medicines Authority is the National Competent Regualtory Authority for Medical Devices.

 

The Medical Devices, Pharmaceutical Collaboration and Entrepreneurship Directorate within the Malta Medicines Authority is responsible for:

  • National Registrations and Notifications: Processing national applications relating to Economic Operators and medical devices.
  • Market Surveillance: Monitoring and enforcing compliance of medical devices on the Maltese market to ensure safety and performance.
  • Post-Market Surveillance and Vigilance: Overseeing post-market activities and addressing incident reports.
  • Notified Body Designation and Oversight: Designating and continuously evaluating the performance of Notified Bodies registered in Malta.
  • Clinical Investigations and Performance Studies: Authorising and overseeing clinical investigations and performance studies for medical devices to ensure compliance with regulatory requirements.
  • EU Collaborative Initiatives: Participating in international fora.

 

By combining rigorous regulatory oversight with proactive collaboration at both national and European levels, the Malta Medicines Authority ensures that the medical devices available in Malta uphold the highest standards of safety and effectiveness, protecting public health and fostering trust in the healthcare system.


Medical Devices Information Hub

Medical Devices News
Stay updated with the latest news bulletins and circulars on medical devices. Click <here> for more information.

Medical Devices Legislation
Access a comprehensive list of all current medical devices legislation. Click <here> to explore.

Medical Devices Interruptions or Discontinuation of Supply
Find the necessary information on Article 10(a) for medical devices. Click <here> for more information.

Medical Devices Applications
Find the necessary applications for medical devices. Click <here> to access the list.

Medical Devices Guidelines
Review the current guidelines governing medical devices. Click <here> for detailed information.

Medical Devices Field Safety Notices
Browse the latest field safety notices for medical devices. Click <here> to view.

General Information relating to Medical Devices
National lists in relation to local activities. Click <here> for additional details.

 

 

Contact Details

Medical Devices, Pharmaceutical Collaboration and Entrepreneurship Directorate
For further inquiries, please reach out via the below email addressed. For activities related to: 

- General queries - devices.medicinesauthority@gov.mt 

- Forms submitted - mdforms.medicinesauthority@gov.mt

- Vigilance and Incident reporting - mdvigilance.medicinesauthority@gov.mt

- Medical Device Inspectorate - mdinspections.medicinesauthority@gov.mt

- Clinical Studies, Notified Bodies, Assessments and Reviews - mdassessors.medicinesauthority@gov.mt