Questions and answers - Fees system for medical device sector stakeholders

Last update : March 2024

1. Definitions

2. General questions

3. Technical questions 

 

1. Definitions

 

The term « individual contribution tax » means the addition of the tax based on the turnover and the activity tax.


The « turnover tax » is calculated on the turnover resulting from making medical devices available to retailers and/or end users on Belgian territory (in accordance with article 14/2 and annex I.1 of the law of 20 July 2006 on the creation and functioning of the Federal Agency for Medicines and Health Products).


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 aforementioned law of 20 July 2006. 


An « end user » is defined as « any natural or legal person, other than a distributor, who uses a medical device in the context of his professional activities » (article 2, § 1, 20° of the aforementioned law of 20 July 2006).


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 » (article 2, § 1, 19°, of the aforementioned law of 20 July 2006).
 

2. General questions

1. Who has to pay the turnover tax?  

All actors that make available medical devices to retailers and/or end users on the Belgian territory (in accordance with article 14/2 and annex I.1 of the aforementioned law of 20 July 2006).

For actors who carry out retail activities, but also supply medical devices to retailers and/or end users, remain subject to the tax. Only their retail activities are exempt.

2. Why do I have to pay an individual contribution when I already pay personal income tax?

The FAMHP is financed by its external partners (such as actors in the medical device sector) for approximately 80%. When it was established, it was determined that the majority of the FAMHP's financial needs would not be met by the patient or the tax payer, but by the sectors under the FAMHP's jurisdiction. The contribution therefore plays a role in the financing of the FAMHP.

3. How is the contribution calculated?

The amount of the individual contribution takes into account two costs:

  • The turnover tax, which is calculated based on the FAMHP budget and the turnover resulting from making medical devices available to retailers and/or end users on Belgian territory (in accordance with art. 14/2 and annex I.1 of the law of 20 July 2006 on the creation and functioning of the Federal Agency for Medicines and Health Products).
  • The activity tax, which 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.

 Contribution = activity tax + turnover tax

The FAMHP budget is devided between the two costs: 75% for the turnover tax and 25% for the activity tax.

For example, if the FAMHP budget is €10,000k:

  • €2,500k (=25% of €10,000k) will be allocated to the activity tax.
  • €7,500k (=75% of €10,000k) will be allocated to the turnover tax.

Calculation of the activity tax:

To calculate the activity tax, it is necessary to first determine the individual cost of an entity, which is the ratio of the FAMHP budget allocated to the activity tax to the sum of all entities of all tax payers. Once this cost per entity has been calculated, the number of entities will be multiplied by this cost.

Calculation of the turnover tax:

To calculate the turnover tax, the percentage of the levy on the declared turnover is determined by taking into account the total declared turnover in the previous year and the budget to be covered.

Exceptions:

  • A taxpayer with a turnover, resulting from making medical devices available, of less than €40,000 indexed, will be exempted from the turnover tax but will still have to pay a contribution that will be calculated solely on the basis of the activity tax.

       Individual contribution = activity tax + tax on individual turnover

  • In addition, this tax can be reduced by one entity if the taxpayer is a distributor and has declared to have complied with the autocontrol guide, on our web portal.
     
  • For a taxpayer who is only a distributor, complies with autocontrole guide and the turnover is less than €40,000 indexed:

    Indivudal contribution = activity tax + tax on individual turnover = 0€
  • A company that is established outside Belgium AND does not carry out any activity on Belgian territory is not considered a taxpayer and therefore does not have to pay a contribution.
4. How is the number of entities in a company determined?

The number of entities in a company is calculated based on the information registered on the FAMHP web portal.

The higher the risk related to the device, the higher the number of entities.

The higher the class of the device, the higher the number of entities.

 

 

Activity subject to the fee

 

 

Authorized representative

Distributor

Importer

Manufacturer

Custom manufacturer

Assembler

STHA

Category of activity subject to the fee

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AIMDD

6

1

3

8

8

 

2

IVDD A

6

1

3

8

 

 

2

IVDD B

2

1

3

4

 

 

2

IVDD other

3

1

3

5

 

 

2

IVDD self-diagnosis

4

1

3

6

 

 

2

IVDR A

3

1

3

5

 

 

2

IVDR B

2

1

3

4

 

 

2

IVDR C

4

1

3

6

 

 

2

IVDR D

6

1

3

8

 

 

2

MDD I

3

1

3

5

 

4

2

MDD IIa

2

1

3

4

 

4

2

MDD IIb

4

1

3

6

 

4

2

MDD III

6

1

3

8

 

4

2

MDD Is/m

3

1

3

5

 

4

2

MDR I

3

1

3

5

5

4

2

MDR IIa

2

1

3

4

4

4

2

MDR IIb

4

1

3

6

6

4

2

MDR III

6

1

3

8

8

4

2

MDR Is/Im

3

1

3

5

5

4

2

 

If the taxpayer is not established in Belgium: reduction of one entity.

If the taxpayer is a distributor applying the self-control system referred to in articles 61 and 62 of the law of 15 December 2013 on medical devices: reduction of one entity.

If the taxpayer has different medical device risk classes for the same activity, the highest number of entities will be taken into account:

E.g. A manufacturer of class I MDR devices (5 entities) and IIa devices (4 entities): the maximum number of entities of the taxpayer = 5

If the taxpayer has several activities, the highest number is taken into account + 1 entity:

E.g. A manufacturer of class I MDR devices (5 entities) and IIa devices (4 entities) who is also an importer of class IIb MDR medical devices (3 entities): maximum number of entities of the taxpayer = 5+1 i.e. 6 entities.

We provide you with a flowchart that will help you calculate the number of entities for your company. 

5. What is the maximum turnover tax rate?

 

Each year N, the FAMHP applies a maximum rate of turnover tax which is determined when the budget is drawn up during year N-1. This budget is partly financed by contributions from the actors in the sector of the medical devices.

The sector's contribution is divided into two costs:

  • 75% for the turnover tax
  • 25% for the activity tax.

Based on the budget, the turnover tax rate and the cost for an entity for the activity tax are then calculated according to this 75%-25% distribution.

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

If the incomes, at the beginning of year N+1 (the end of the accounting year N), are higher than the expenses, the turnover tax rate is reduced. It is then effectively this reduced rate that will be applied to the invoice that will be sent to you. On the other hand, if the exercise results in a loss, the maximum rate is applied (without being increased to make up the deficit).

The cost per entity remains fixed and will only be reviewed when the budget for the following year is drawn up.

 

6. I have a turnover related to medical devices for activities subject to the contribution that is less than €40,000 indexed. Do I have to submit a turnover declaration? Will I have to pay?

In this case, you must still complete the turnover declaration and tick the box "I declare that my turnover relating to medical devices for activities carried out in Belgium and subject to the contribution is less than € 40,000 indexed".

Even if your turnovers is below the limit of the turnover tax, you will still have to pay the activity tax.

 

7. I received an email to fill in the contribution form but my company is not located in Belgium and does not carry out any activities on Belgian territory. What should I do?

In this case, you must still fill in the turnover declaration and tick the box "I declare that my company is not located in Belgium and does not carry out any activity subject to the contribution on Belgian territory" . In this case you are deemed not to be subject to the contribution and you do not have to pay anything. We also ask you to close your activities registered on the portal.

8. I don't want to submit a turnover declaration to the FAMHP; what am I risking?

If no declaration is made, the FAMHP itself will determine the contribution to be paid on the basis of the total turnover as known to FPS Finance. In addition, if the taxpayer fails to meet its obligations with regards to the contribution, he will owe an administrative fine and interest of 0,8 % of the amount due (article 14/17 of the law of 20 July 2006 on the establishment and operation of the FAMHP).. In addition, not complying with the obligation to declare your turnover also increases the probability of being visited on your premises by our inspectors.

9. When will I receive the invoices?

For the activity tax, the payment notice is generally sent at the end of the year. For the turnover tax, the payment notice is sent during the year following your turnover declaration. In both cases you will receive an invoice from our accounts department showing the amount to be paid and the structured communication. Wait for this invoice before making your payment.

10. My company started its activities in December of year N-1. Do I have to declare my turnover for year N-1 during year N?

Yes, in this case you must complete the turnover declaration (relating to making medical devices available to retailers and/or end users on Belgian territory). This declaration must be completed in year N by all companies that carried out an activity subject to the contribution in year N-1 (regardless of the date on which the activity started).

If your activity started at the end of the year N-1, it is possible that your turnover for the year N-1 is lower than €40,000 indexed. In this case, the amount of the individual contribution will only take into account the activity tax and not the turnover tax.

11. I registered an activity related to medical devices on the FAMHP portal during year N-1, but my activity only started in January of year N. Do I have to declare my turnover for year N-1 and pay the contribution for this activity?

From the moment your acivity is known, you represent a workload for the FAMHP and you will therefore have to complete your turnover declaration. In this case, your turnover for year N-1 will probably be less than €40,000 indexed. The amount of the individual contribution will therefore only take into account the activity tax and not the turnover tax.

12. I carried out an activity related to medical device activity in year N-1 but stopped it in year N-1. Do I have to declare my turnover for this activity and pay the corresponding contribution?

Yes, in this case you must complete the turnover declaration. It must be completed in year N by all companies that carried out an activity subject to the contribution in year N-1 (even if the activities stopped during the year). From year N+1, you will no longer have to fill in a turnover declaration.

13. . I registered an activity related to medical devices on the FAMHP portal a long time ago but I no longer perform this activity. Do I have to pay the contribution?

From the moment your activity is known, you represent a workload for the FAMHP and you will therefore have to complete your turnover declaration, even if you no longer carry out this activity. In this case, your turnover for year N-1 will be less than €40,000 indexed. The amount of the individual contribution will therefore only take into account the activity tax and not the turnover tax.

To stop paying the contribution, you must close your registered activity on the portal. You will need to complete your declaration one last time in the year following the closure of your activity.

14. I have not yet registered my activity on the portal. Do I have to pay the contribution?

Yes, all actors must declare their turnover.

Furthermore, if you are not registered on our portal, you will be liable for a higher annual tax. If you have not declared at least one activity, the calculation will take into account the maximum number of entities by default, i.e. 9 entities.

15. I carry out one or more activities related to medical devices and subject to contributions, but not in Belgium. Do I have to pay the contribution?

That will depend on your situation.

The contribution must be paid by:

  • Actors located in Belgium with an activity subject to contribution even if this activity is not carried out in Belgium. For example, an importer located in Belgium who only makes devices available on French territory, is subject to the contribution because he is located in Belgium. However, the turnover to be declared will be zero and the amount of the individual contribution will be based solely on the activity tax.
  • Actors located abroad but carrying out an activity subject to the contribution on Belgian territory. For example, a manufacturer located in Germany and that places their own products on the Belgian market is subject to the cintribution.

If you are an actor located abroad AND you do not carry out any activity subject to the contribution on Belgian territory, you do not have to pay the contribution but we ask you to close your activities registered on the the portal

16. My company carries out an activity subject to the contribution but also rents these medical devices. Should the turnover of these activities also be taken into account for the calculation of the contribution?

Yes, a device is made available on the market when it is supplied for distribution, consumption or use. The transfer of a device is therefore deemed to have taken place, in particular, in the context of a sale, loan, rental, lease or gift. Transfer of ownership implies that the device is intended to be made available to another physical person or legal entity.

Renting is considered as making the device available on the market. Consequently the renting of medical devices to retailers and end-users must be taken into account when calculating the contribution.

17. I carry out several activities for which I am liable to pay a contribution. Will I have to pay more?

If you carry out several activities subject to the contribution, the cost of the activity tax will be slightly higher, which will result in a higher amount of contribution than if you only had one activity.

In concrete terms, the activity with the highest number of entities is taken into account and one more entity is added:

Example: A manufacturer of class I MDR devices (5 entities) and IIa devices (4 entities) and which is also an importer of class IIb MDR medical devices (3 entities): maximum number of entities of the taxpayer = 5+1 i.e. 6 entities.

This additional entity is added only once when you perform two or more activities subject to the contribution and not for each additional activity (only one entity is added regardless of whether you perform two, three or four activities subject to the contribution).

18. I am a dentist who buys devices (these may be CE-marked raw materials) and then distributes them to dental laboratories. These intermediate products are intended to be incorporated into the custom-made device that the dental laboratory will manufacture. Do I have to pay the contribution?

In this situation, the dentist acts as a distributor. If these intermediate products are purchased in a non-EU country, the dentist acts as an importer. If you carry out at least one of these activities, you are liable to pay the activity tax.

For the turnover tax, you are liable for making medical devices available to retailers and/or end users.

An end user is defined as « any natural or legal person, other than a distributor, who uses a medical device in the context of his professional activities ».

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 ».It is important to know that importers and distributors have obligations under both the European Medical Device Regulation and national legislation.

It is important to know that importers and distributors have obligations under both the European regulation on medical devices and national legislation.

19. Can a third party (e.g. one of my suppliers) pay the individual contribution for me?

Yes, a third party can pay the contribution on your behalf, but the contribution must be calculated on the basis of your company's information (activity(ies) and turnover). You remain solely responsible for paying your contribution.

20. What turnover should I declare?
  • Total annual sales of medical devices in Belgium. This turnover will not be invoiced.

  • The annual turnover relating to the sale and provision of medical devices to retailers and end users in Belgium.   This is the turnover that will be invoiced.  

21. Can the declaration form be signed by an internal accountant?

Yes, this is allowed.

The form should be certified by an auditor or chartered accountant (in accordance with article 14/6 of the law of 20 July 2006 on the creation and functioning of the Federal Agency for Medicines and Health Products).

 

3. Technical Questions 

22. How do I access the "Contributions" application?

There are two ways to log in to the "Contributions" application: 

  • by clicking on the link in the email that you received inviting you to complete the turnover declaration. 
  • Go to the FAMHP web portal with authentication. To do so, do the following: 
page accueil portail
  1. via your web browser, go to the FAMHP web portal via your web browser:https://www.vas.ehealth.fgov.be/portal/en/.
  2. Click on "Go to the module for actors in the medical devices sector". 
  1. Click on "Login". 2 logins possibilities
    1. For Belgian companies: log in via your identity card or itsme®.
    2. For foreign companies: log in via the TOTP ("Time-based-One-Time-Password") system, which grants a new password every "x" seconds, via smartphone (e.g. Google Authenticator, Microsoft Authenticator). 
manage my contributions
  1. When you are logged in, click on "manage my contributions" in the "Contributions" box. 
Role
  1. Choose the "Enterprise User" role from the drop-down menu and click "Continue". 
  1. You are now in the "Contribution" application.

 

23. I have access to the FAMHP portal but not to the "Contributions" application; what should I do?

Each application on the portal requires a specific access right. This implies that users who need to access the "Contributions" application must have specific access to this application.

To set up the access right, the company's Primary Access Manager (PAM) must connect to the Social Security site and follow the steps in our guides:

  • In point 4 of the guide for companies located in Belgium.
  • In point 3.2.2 of the guide for companies located outside Belgium.

The PAM must verify that the "contributions" box has been ticked for the user in the secure applications list.

page accueil portail
24. I get an error message when I try to login to the portal. What should I do?

There may be several reasons:

  • It might be a problem with your web browser. There are several solutions you can try to solve the problem:
    • make sure you are using the latest version of your browser.
    • do not use Internet Explorer or Edge, as our applications are not optimised for these browsers.
    • try to login using another browser, e.g. Firefox or Chrome.
    • delete the cookies and restart your browser.
    • try to log in by opening a private browser window.
  •  Sometimes, the access authorisation from social security is not sent directly to our applications. You have to wait until the next day to be able to log in.
  • You are not designated as a manager or user of our applications. Please refer to our portal user guides to resolve this issue: 
  • Guide for companies located in Belgium.
  • Guide for companies located outside Belgium.

 If none of the above actions have resolved the problem, please email us at support.portal@fagg-afmps.be with a screenshot of the Social Security site showing your access details. Technical support can also be reached by phone on +32 2 528 48 56.

25. How do I create a profile to access the FAMHP portal?

The FAMHP provides user manuals for the web portal which contain all the necessary information:

  • Guide for companies located in Belgium.
  • Guide for companies located outside Belgium.

We also provide FAQ specific to the portal, which addresses a number of questions, especially technical ones.

 

Last updated on 11/03/2024