Fees based on the turnover made in Belgium and payments


Contribution and tax based on turnover

The financing system for the medical devices sector consist of two components:
- The annual contribution for economic operators 
- The annual turnover tax.


Contribution for economic operators


It is calculated on the basis of 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 2024 (2023 turnover declaration), the cost of one entity is 379.48 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

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 tax. Only their retail activities are exempt.

The turnover tax rate is a maximum rate. For 2024, this maximum rate is set at 0.2868%

The minimum turnover threshold from which this tax is due is €40,000 indexed (= €48,798.42).


•    Individual case 1

A taxpayer with a turnover lower than €40,000 indexed is exempted from the turnover tax. However, the contribution for economic operators must be paid. 

•    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 the contribution for economic operators. Moreover, if the turnover is lower than €40,000 indexed, the taxpayer is also exempted from the turnover tax, and will therefore not have to pay anything. This does not mean that the declaration should not be completed. 


How to declare my turnover

In order to declare your turnover, you have to use the ‘Contributions’ application.

To declare your turnover, please use the form 'Declaration’ (FR-NL-EN-DE). The declaration should be certified by an auditor or chartered accountant. The document has to be scanned and uploaded into the application. 

For your 2023 turnover declaration, we ask you to declare:

1) The total annual turnover relating to medical devices for activities subject to the contribution. This turnover will not be invoiced.

2) The annual turnover relating to the sale and supply of medical devices to retailers and end users. This turnover will be used to calculate your turnover tax.

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.

Do you have any questions?

Please read the ‘question and answer’ document first. If you still have questions, you can contact us via the address contributions.meddev@fagg-afmps.be.

Last updated on 02/04/2024