Medical Device Registration in
Malta
Ministry of Health:
Regulatory 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