A
A
A
Patient / Consumer
Know more about Medicines Regulation Know more about access to medicines which do not have a Marketing Authorisation Report a Side Effect Biological and Biosimilar Medicinal Products How we monitor the safety of medicines Know more about the Medicines Supply Chain Know more about Use of Medicines Information Leaflets on Medicines Search for your Medicines
Industry
Pharmaceutical Activities and Inspections Product Quality Defects Reporting Scientific Advice Advertising Registering a product Pharmacovigilance Fees
Health Care Professionals
Search Authorised Medicines in Malta Adverse Drug Reaction Reporting How we monitor the safety of medicinal products Safety Information Clinical Trials Product Quality Defects Reporting Medicines supply chain and regulation Advertising
Home / Medical Devices

Medical Devices

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 Device and Pharmaceutical Collaboration 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 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.

Medical Devices and Pharmaceutical Collaboration Contact Details
For further inquiries, please reach out via email at:
General Queries - devices.medicinesauthority@gov.mt
Application Queries - mdforms.medicinesauthority@gov.mt
Vigilance Queries - mdvigilance.medicinesauthority@gov.mt
Inspections Queries - mdinspections.medicinesauthority@gov.mt