Medical Device Governance Fund: Ministry of Health sets out how companies in the sector will pay 0.75% of turnover

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With the decree of 29 December 2023, published in the Italian Official Gazette on 9 February 2024, the Ministry of Health has established the criteria and methods for feeding the “Fund for the Government of Medical Devices.” The Ministry said that “starting from the current year, from 1 November to 31 December of each year, companies producing or distributing medical devices and large medical equipment and in vitro diagnostic medical devices shall pay, on revenue chapter no. 3616, the annual fee provided for in Article 28 of Legislative Decree No. 137 of 2022 and Article 24 of Legislative Decree No. 138 of 2022, corresponding to 0.75% of the value of turnover.” Companies have to self-declare the amount every year.

So, starting this year, medical device companies will have to pay a new form of contribution in addition to the pending payback issue. But they will still have the right to appeal before the Administrative Judge under the terms of the law.