19/04/2024
Medical Device Alert Medical Device Voluntary Recall
Details on the Physiomer Baby Unidose medical device recall can be found <here>.
11/09/2023
Ref:MA-MDPCD-002-2023 Notice to Stakeholders – Product Notification relevant to Medical Device Regulatory Sciences in Malta
The Malta Medicines Authority issues a notice to economic operators in Malta to notify the Authority with medical devices being makde availble on the Maltese market, in line with Subsidiary Legislation 458.59 Medical Devices and In Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulation.
Application and Guidelines are available on <here>.
Notice can be downloaded below.
21/07/2023
Ref: MA/MDPCD-001/2023: Notice to Stakeholders – Organisation Registration relevant to Medical Device Regulatory Sciences in Malta
The Malta Medicines Authority issues a notice to economic operators in Malta to register their organisation with the Authority, in line with Subsidiary Legislation 458.59 Medical Devices and In Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulation.
15/04/2022
The Malta Medicines Authority informs the public that the Authority has issued applications welcoming submissions from distributors to make available Covid-19 Self-Test Kits.
A list of approved Self-Test Kits is available on the Authority’s website https://medicinesauthority.gov.mt/mdinfo. Currently, the list has 5 approved Covid-19 Self-Test kits, with other applications under review.
12/04/2022
The Malta Medicines Authority will be hosting an online seminar tackling Covid-19 Self-Tests and the process to reach market on 13 April 2022.
The seminar will be repeated on 18 April 2022 for those who could not attend the first seminar.
Should you wish to attend kindly send a request on devices.medicinesauthority@gov.mt
17/03/2022
The Malta Medicines Authority will be hosting an online seminar tackling Organisation Registration & MDRP applications on 21 March 2022.
The seminar will be repeated on 28 March 2022 for those who could not attend the first seminar.
18/10/2021
The Medical Device Unit has issued fact sheets for local economic operators. The fact sheets describe the obligations and responsibilities for each operator in an user friendly manner.
Click <here> to go to the guidance page to view and download the fact sheets.
18/01/2021
The Malta Medicines Authority will be hosting an online seminar tackling Eudamed - Actor Registration Module.
A copy of the presentation given can be found <here>.
19/10/2020
The function of the national competent authority for medical devices and in-vitro diagnostic medical devices is being transferred from the Malta Competition and Consumer Affairs Authority to the Malta Medicines Authority. Both entities fall within the portfolio of Parliamentary Secretary for Consumer Protection and Public Cleansing within the Ministry for Tourism and Consumer Protection. This transfer falls within ACT VII of 2020 to amend Medicines Act Cap458, and its subsidiary Legal Notices 318-321 of 2020.
Through this transfer, the same robust framework safeguarding safety, efficacy and quality adopted for the regulation of medicines will be applied to medical devices as is the case in 28 out of 31 European Agencies. Both authorities are working in tandem to ensure a smooth transition which is patient centred. To this end, a successful stakeholders meeting was held last July. The Malta Medicines Authority and the Parliamentary Secretary would like to recognise the efforts and contribution of all stakeholders working as a team to meet patient and European directive needs with regards to the quality, safety and efficacy of medical devices on the local market.
Further information can be obtained from www.medicinesauthority.gov.mt. Queries may be addressed to devices.medicinesauthority@gov.mt.