Medical Device Regulatory Requirements in Malta
| Regulatory Authority |
Malta Medicines Authority |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Medical Devices Legislation
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
(EU) 2017/746
| Click Here
|
| Registration Process |
Guidance for Application for Organisation
Registration in relation to Medical Devices
| Click Here
|
| Registration Timeline |
For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Maltese and/or English Language |
| Adverse Event Reporting Form |
Download |
| Additional Information |
The Medical Device Unit, through a national centralised management system, carries out registration of local Economic Operators, the listing of medical devices placed on the local market and a reporting system for medical device incident reports. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025