Medical Devices Forms

E-Forms

Please find below the list of e-forms related to Medical Devices.

 

MT-MDF01 Application for Certificates of Free Sale for Medical Devices - <Link>

MT-MDF02 Application for Organisation Registration in relation to Medical Devices - <Link>

MT-MDF03 Application for Medical Device Registration - <Link>

MT-MDF06 Application for Designation of a Notified Body for Medical Devices - <Link>

MT-MDF07 Application for Designated Premises for COVID-19 - <Link>

MT-MDF10 Application for Notification of Point-of-Care Covid-19 Test or Device for Self-Testing for Covid-19 - <Link>

MT-MDF11 Application for Medical Device Registered Person (MDRP) - <Link>

 

Incident Report Forms

Health Care Professional Incident Report Form - <Link>

Public Incident Report Form - <Link>


Templates to be Uploaded on e-forms

Excel Sheet for Application MT-MDF01 - Certificate for Free Sale - <Link>

Excel Sheet for Application MT-MDF03 - Medical Device Registration - <Link>

Excel Sheet for Application MT-MDF05 - Medical Device Notification - <Link>


Declaration Form

A declaration form should be attached to the e-form and submitted online for each e-form.

The declaration form can be found <here>.

 

Guidance documents on medical devices can be found through the following <link>

 

All forms should be submitted to mdforms.medicinesauthority@gov.mt