Medical Device Registration in


Ministry of Health:     

Ministry of Health

Regulatory Authority:          

Malta Medicine Authority

Medical Device Regulation:          

Medical Devices And In-Vitro Diagnostic Medical Devices Provision On The Maltese Market Regulations S.L.458.59

EU MDR 2017/745

Official Language:      

Maltese, English


Class I, IIa, IIb and III

Medical Devices Registration in Malta:

  • Determine the device classification
  • Appoint Authorized representative and Notified Body
  • All devices must bear a CE mark
  • The Notified Body audits the manufacturer for Conformity Assessment.
  • The Notified body submits the documentation to the Competent Authority
  • Once approved, the device can be marketed

Documents Required:          

  • CE Certificate
  • Technical File
  • Declaration of Conformity
  • Clinical Evaluation Report (CER)
  • Risk Management File
  • QMS certificate
  • Labelling

Post-market surveillance:  

Adverse event report,

  • Serious public health threats – 2 day
  • Death or serious health deterioration – 10 days
  • Other serious incidents – 15 days

Applicable QMS:          

ISO 13485

Registration Timeline:         

Class I – 4-6 weeks

Others – Based on Notified Body timeline

Authorized Representative:          


License Validity:          

5 years

Want to know more about this registration process?