Activity tax and tax based on turnover
The new financing system for the medical devices sector consist of two components:
- The annual contribution from economic operators (the activity tax)
- The annual turnover tax.
The activity tax is calculated based on the FAMHP budget and a risk analysis related to the device and therefore the workload involved for the FAMHP. The risk analysis 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.
If you do one or more of the following activities you have to be registered in our online applications: manufacturer, custom-made device manufacturer, assembler (systems and kits), authorized representative, distributor, importer and companies which, as part of a patient's medical treatment outside a hospital, install and/or maintain medical devices.
Tax based on turnover
As for the tax based on turnover, the rate has been reduced due to the introduction of the activity tax. The turnover tax remains limited to the turnover resulting from the making available of medical devices to retailers and/or end users on Belgian territory, in accordance with article 14/2 and annex I.1 of the aforementioned law of 20 July 2006.
An end user is defined by article 2, § 1, 20° of the aforementioned law of 20 July 2006 as « any natural or legal person, other than a distributor, who uses a medical device in the context of his professional activities ».
Retailers, as defined in article 2, § 1, 19°, of the aforementioned law of 20 July 2006, remain exempted from this tax. A retailer is defined as: « any natural or legal person who supplies devices to consumers, namely any natural person who acquires or uses devices exclusively for non-professional purposes ».
For actors who carry out retail activities, but also supply medical devices to retailers and/or end users, the latter activities remain subject to the tax. Only their retail activities are exempt.
The minimum turnover threshold from which this tax is due is €40,000 indexed (= €47,660.56).
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 pay a contribution.
• Individual case 1
A taxpayer with a turnover lower than 47.660,56 euro is exempted from the turnover tax. However the activity tax must be paid.
If the turnover is lower than 47.660,56 euro: the individual contribution = activity tax
• Individual case 2
A taxpayer who is only a distributor and who has declared in the online applications of the FAMHP that he complies with the self-check guide is exempted from activity tax. Moreover, if the turnover is lower than 47.660,56 euro, the taxpayer is also exempted from the turnover tax, and will therefore not have to pay a contribution. This does not meant that the declaration should not be completed.
How to declare my turnover
1. You have not yet submitted a declaration:
In order to declare your turnover, you have to use the ‘Contributions’ application.
To declare your turnover, please use the form 'Declaration’ (EN - NL - FR - DE). The declaration should be certified by an auditor or chartered accountant. The document has to be scanned and uploaded into the application.
You have until 15 September 2023 to submit your declaration.
2. You have already submitted your declaration, but it needs to be amended:
To correct your turnover, you have to use the 'Contributions' application.
You can directly access the online introduction form of your turnover by clicking here or via the following web page subject to authentication: https://www.vas.ehealth.fgov.be/webmedseip/fr.
To correct your turnover, please use the form 'Declaration’ (EN - NL - FR - DE). The declaration should be certified by an auditor or chartered accountant. The document has to be scanned and uploaded into the application.
You have until 15 September 2023 to do it.
3. You have already submitted your declaration and it does not need to be amended:
In this case, you have nothing further to do.
At the beginning of the next calendar year, you will receive an invoice from our Budget and Management Control Division with the amount to pay and the structured reference. Please wait for this invoice before making your payment.
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.