Malta Medicines Authority designated as the competent authority for medical devices

Published: 19 Oct 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.

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