Governed by the European Union Medical Device and IVD Regulations (EU 2017/745, 2017/746)
| 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 |
| Device Classification Guidelines | MDCG 2021-24 Guidance on classification of medical devices | 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 |
| Clinical Trials Information |
The Clinical Trials Information System (CTIS) will act as the single entry point for clinical trials authorisation and supervision in the EEA. The exchange of information between sponsors and Member States and among Member States will be fully electronic within the CTIS system. This includes the clinical trial application dossier, requests for supplementary information, Annual Safety Reports, clinical trial amendments, corrective measures and other day-to-day business processes. | Click Here |
| Certificate of Free Sale |
Guidance for Application for Certificates of Free Sale for Medical Devices | Click Here |
| Field Safety Corrective Action |
Field Safety Notices (FSNs) are crucial communications issued by manufacturers or authorized representatives when a medical device presents a potential safety issue or requires corrective action. These notices are vital to maintaining the safety, quality, and effectiveness of medical devices in the healthcare system. | Click Here |
| Advertising and Promotions |
Regulation of Advertising of Medicines | Click Here |
| 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. |
| Contact Phone | 300000356 2343 9000 |
| Contact Email | info.medicinesauthority@gov.mt |
| Contact Address | Medicines Authority Sir Temi Żammit Buildings Malta Life Sciences Park, San Ġwann SĠN |