Fee based on turnover for financing the FAMHP's medical device activities
General information
How to declare my turnover
Questions and answers
Legal basis
Download the declaration form
Fees for medical devices
Fee based on turnover for financing the FAMHP's medical device activities
General information
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. The fee must also be paid by actors established abroad who carry out an activity subject to the fee on Belgian territory. For example, a manufacturer established in Germany who introduces his own products on the Belgian market from Germany is required to pay the fee.
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).
The amount of the individual contribution takes into account two costs.
• The activity tax, which is calculated based on the FAMHP budget and the level of responsibility in relation to the device and therefore the workload involved for the FAMHP. This level of responsibility is based on the number of entities per activity as described in Chapter III of Appendix IX of the Law of 20 July 2006 on the creation and functioning of the Federal Agency for Medicines and Health Products). For 2023 (2022 turnover declaration), the cost of one entity is 367.11 euro.
We provide you with a flowchart that will help you calculate the number of entities for your company.
• The tax based on turnover, which is calculated based on the FAMHP budget and the turnover in relation to the medical devices of the taxpayer. For 2023 (turnover declaration 2022), the maximum rate of this tax is 0.2762%. The minimum turnover threshold from which this tax is due is €40,000 indexed (= €47,660.56).
The basic rule is therefore: the individual contribution = activity tax + tax based on turnover.
The full details of this calculation as well as the different criteria taken into account for this calculation are included in our Q&A document.
• Individual case 1
A tax-payer with a turnover for medical devices of less than 40,000 euro will be exempt from sales tax. The activity tax will be calculated and paid.
If the turnover is lower than 40,000 euro: the individual contribution = activity tax
• Individual case 2
A tax-payer who is only a distributor and who has declared in our online applications that they comply with the self-check guide will be exempt from activity tax. Moreover, if their turnover is lower than 40,000 euro, they will also be exempt from tax based on turnover, and will therefore not have to pay a contribution. This does not exempt him from completing his declaration.
• Individual case 3
A company located outside Belgium AND not carrying out any activity on Belgian territory is not considered a taxpayer and therefore does not have to make an advance payment.
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.
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 the document (available to download below) 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.
Fees system for medical device sector actors – EN
Système de redevance pour les acteurs du secteur des dispositifs médicaux – FR
Systeem van bijdragen voor actoren in de sector van medische hulpmiddelen – NL
Gebührensystem für Akteure im Bereich Medizinprodukte - DE
Legal basis
All the stakeholders listed in the table below are currently liable for the contribution if they are established in Belgium or are established abroad but carry out an activity in Belgium.
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.
| Payer of contributions | Activity subject to contribution |
| The authorized representative: any natural or legal person established in the European Union (EU) who has received and accepted a written mandate from a manufacturer located outside the EU to act on behalf of the manufacturer to complete determined tasks linked to the obligations incumbent upon the latter in virtue of this regulation. | The performance of the authorized representative’s activity. |
| The distributor: any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service. | The placing of a medical device on the market as a distributor. |
| The importer: any natural or legal person established within the EU that places a device from a third country on the EU market. | The placing on the market of medical devices from third countries. |
| The manufacturer: a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark. | Manufacturing or refurbishing a medical device, or having a medical device designed, manufactured or refurbished, and marketing it under its name or trademark. |
| The manufacturer of custom-made devices: a natural or legal person who manufactures or fully refurbishes a custom-made device or has a custom-made device designed, manufactured or fully refurbished, and markets that custom-made device under its name or trademark. | Manufacturing or refurbishing a medical device, or having a medical device designed, manufactured or refurbished, and marketing it under its name or trademark, when it is a custom device as referred to in Article 2, 3) of Regulation (EU) 2017/745. |
|
Assemblers of systems and procedure packs: any natural person who combines devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack. b) in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746; c) other products which are in conformity with the legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified. Or any natural person who sterilises systems or procedure packs. |
The placing on the market of a system or procedure pack as referred to in Article 22(1) and/or (3) of Regulation (EU) 2017/745 |
|
STHAs: companies that install and/or maintain medical devices as part of a patient's medical treatment outside a hospital. |
The installation and/or maintenance of medical devices as part of a patient's medical treatment outside a hospital |
Download the declaration form
Download the form in the language of your choice.
Declaration of turnover - FR
Declaration of turnover - NL
Declaration of turnover - EN
Declaration of turnover - DE
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The form must be completed by an auditor or chartered accountant. It must then be sent via the "My contributions" application of the FAMHP, available on the web portal of the FAMHP.
Fees for medical devices
The monitoring of the medical devices market is also financed by fees for service and reinspection fees.
A fee for service is an individual cost for a specific request (certificates for over-the-counter sales, clinical investigation, etc.). This is a single cost per request for the applicant.
Reinspection fees relate to any additional inspection made necessary as a result of the finding, during a previous inspection, of one or more infringements of the legislation and/or deficiencies in relation to the regulations and/or standard in force (Article 90, 33 of the Programme Law of 26 December 2022).
The main amounts of these fees are listed in the "medical devices" table on the Contributions and fees page.