03/2023 - Medical Device Actors in Belgium - new system for fees
From 2023 onwards, a new system for financing the surveillance of medical devices is installed by the FAMHP(Belgium). The new system aims to divide the fees in a fair way between the different stakeholders in the sector, whereas in the past the fees were only paid by the actors distributing to retailers and end-users.
Under the new financing system, all actors active in the field of medical devices must submit a turnover declaration via the web portal of the FAMHP. Based on the declaration, a fee will be calculated. The fee must also be paid by actors established abroad who carry out an activity subject to the fee on Belgian territory. For example, an Italian manufacturer who introduces (i.e. invoices) medical devices on the Belgian market is required to pay the fee and thus submit a declaration.
Any company, whether based in Belgium or abroad, who performs one of the following roles in the medical device field in Belgium, needs to double-check whether they are liable to pay the fee:
• authorized representative
• assembler of systems and procedure packs
• manufacturer of custom-made devices
• companies servicing or maintaining medical devices
The declaration is due in 2023, the payment is due in the next calendar year, but rest assured, an invoice will be sent by the FAMHP!