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

Classification:    

Class I, IIa, IIb and III

Registration Process:

• 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:          

Yes

License Validity:          

5 years