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Home / Medical Devices / Medical Devices Information

Medical Devices Information

Comprehensive Medical Device Information

 

What You'll Find

Our medical device information includes:

  • Regulatory Guidelines: Detailed explanations of the European and Maltese regulations governing medical devices.
  • Device Safety and Performance: Insights into ensuring devices meet safety, functionality, and quality standards.
  • Economic Operator Responsibilities: Guidance for manufacturers, importers, and distributors on their roles and obligations.
  • Incident Reporting: Information on reporting and addressing medical device-related issues, ensuring public health protection.
  • Market Entry Requirements: Steps for registering devices and placing them on the Maltese market.
  • Educational Materials: Resources to promote awareness about medical device use and compliance.

 

Supporting a Safe and Effective Healthcare System

By providing clear and accessible information, we aim to foster transparency, trust, and compliance in the medical device sector. Whether you're a professional navigating regulatory processes or a member of the public seeking device-related knowledge, this hub serves as your go-to resource.

 

For further inquiries, please reach out to the Medical Device and Pharmaceutical Collaboration Directorate at devices.medicinesauthority@gov.mt.

 

National Lists:

Registered Medical Device Organisations List

Medical Device Registered Person (MDRP) List

Rapid Antigen Test (RAT) Professional Use List

Covid-19 Self-Test List