Proposed amendments to the Medicines Act will pave the way for stronger oversight of medical devices, effectively putting them on par with medicines, Health Minister Chris Fearne said this morning.
The bill would serve to implement new EU regulations on medical devices which had been approved on May 2017 – Fearne highlighted that this occurred when Malta held the presidency of the Council of the EU. Member states are bound to regulate medical devices by May, and regulate in vitro diagnostic medical devices by May 2022.
It effectively empowers the minister responsible for health to prescribe regulations concerning medical devices, including their authorisation, inventory and quality controls, as well as inspections of the premises manufacturing them. It also sets out that anyone found in breach of these regulations would be subject to fines ranging from €12,000 to €120,000, and/or imprisonment for up to two years.
These powers largely reflect the existing state of affairs when it comes to the regulation of medicines, and Fearne emphasised that the difference in the way medicines and medical devices were regulated was an anomaly which long needed to be addressed.
Among other things, the minister highlighted that while the Medicines Authority was responsible for the regulation of medicines, medical devices were still being regulated by the Malta Competition and Consumer Affairs Authority: a state of affairs that will be changed as a result of the bill.
The bill was ultimately approved without a vote, with PN health spokesman Stephen Spiteri welcoming the proposed amendments.
He noted that as a medical doctor, he was well aware of the need to ensure that he does no harm when treating patients, and that consequently, there was the need to ensure that medical devices would not lead to any adverse collateral effects.