A new system for financing the surveillance of the medical devices market applies from 2023. This system aims to make fees fairer between the different stakeholders in the sector, as each one must pay a fee that is consistent with its turnover and with the level of risk involved in its activity and in the workload it represents for the FAMHP.
Until now, only stakeholders providing medical devices to retailers or end users in Belgium had to pay this fee to the FAMHP. With the new financing system, all actors active in the field of medical devices must file a turnover declaration.
Who is liable to pay the contribution?
You are liable for the contribution if you perform at least one of the following roles in the medical device field in Belgium:
• manufacturer
• authorized representative
• importer
• assembler of systems and procedure packs
• manufacturer of custom-made devices
• distributor
• company referred to in Article 59 of the Law of 15 December 2013 regarding medical devices (service and technical home assistance (STHA) activity).
How to declare my turnover?
At the start of every year, you will receive an e-mail asking you to submit your turnover for medical devices for the activities carried out in Belgium and subject to contributions. The turnover to be notified is that of the previous year.
You can submit your turnover via the FAMHP-application "My contributions", available on the web portal of the FAMHP.
You must use this same application to provide a document completed by your auditor or chartered accountant.
At the beginning of the following year, you will receive an invoice from our Budget and Management Control Division with the amount to pay and the acceptance giro. Wait for this invoice before making your payment.
Legal basis
The tax system is legislated by Articles 14/2 to 14/6 of the Law of 20 July 2006 relating to the creation and operation of the Federal Agency for Medicines and Health Products. The parties and activities liable for the contribution are listed in Annex IX of this same Law of 20 July 2006, inserted by Appendix VIII of the Law of 26 December 2022.
For more information
Remuneration and fees