As from the start of 2023, a new system for funding market surveillance of medical devices by FAMHP applies. Unlike before, this will no longer be limited to the sale of medical devices to retailers and end users. All actors that carry out an activity regarding the distribution of medical devices on Belgian territory are now liable for the contribution (i.e. Manufacturer, Importer, Distributor, Assembler of systems and kits, etc.).
The aim of this system is a more equal system of contributions between the various actors in the sector, each of whom will have to pay a contribution in line with their turnover, on the one hand, and the level of risk associated with their activity and the workload they represent for the FAMHP, on the other.
So double check Remuneration and fees, because it is very well possible that you didn’t need to pay the contribution over the past years, but now you do.
The 2022 turnover declaration relating to medical devices for activities carried out in Belgium subject to the contribution must be submitted by 30/06/2023 at the latest.