Fees based on the turnover made in Belgium and payments

Charge based on turnover to fund AFMPS activities in the area of medical devices

According to Article 34 of the Law of 15 December 2013 on medical devices, as amended by Article 133 of the programme Law of 19 December 2014, a contribution of the amount of 0.38492% of the programme for the previous calendar year on the Belgian market with a minimum of €500 is due from distributors who have delivered medical devices to end users or to those responsible for issuing such devices.

The turnover declaration has to be sent before the 1st of April of the current year to the address below this page.

On the basis of this declaration, the AFMPS will calculate the amount due and send the payment request by registered letter with acknowledgement of receipt.

The transfer must be made within 14 days of receipt of the notice for payment.

 

Exceptional contribution based on turnover for the National Sickness-Invalidity Insurance Institute.

For 2015, Article 46 of the Law of 15 December 2013 on medical devices as amended by Article 134 of the programme Law of 19 December 2014 stipulates that an exceptional contribution must be paid by distributors who have delivered medical devices to end users or to those responsible for their issuance in Belgium.

This contribution is 0.13% of the turnover for the current calendar year on the Belgian market.  The AFMPS shall receive the contribution on behalf of the INAMI. 

 

Payment of the exceptional contribution shall be divided into two phases:

- First phase: transfer of an instalment calculated on the basis of the turnover for the previous calendar year. The turnover for the previous calendar year is the basis for an initial estimate of the turnover for the current calendar year.  This operation takes place at the same time as the "Charge based on turnover to fund AFMPS activities in the area of medical devices".

- Second phase: transfer of the balance calculated on the basis of the turnover for the current calendar year.

Ex: For the exceptional contribution for 2015: your turnover on your medical devices distribution business for end users and those responsible for their issuance on the Belgian market was €100,000 in 2014 (previous calendar year); you will pay an instalment of €130 in 2015 (current calendar year) At the end of 2015, if your turnover is €103,500, the balance of €4.55 will be payable.

On the basis of the turnover declaration, the AFMPS will calculate the amount due and send the payment request by registered letter with acknowledgement of receipt.

The transfer must be made within 14 days of receipt of the notice for payment.

 

Payments concerning medical devices

The payments concerning active implantable medical devices (AIMD) are shown in the Royal Decree dated 15th July 1997 and in the  Royal Decree dated 10/12/2002.

 

The payments concerning activities related to medical devices (MDD) are shown in the Royal Decree dated 1st March 2000 and in the Royal Decree dated 13th May 2005 modifying the Royal Decree dated 1st March 2000. The main amounts are as follows:

 

Notification of an AIMD clinical evaluation            2398,79 €

Notification of an MDD clinical evaluation             2291,03 €

Notification of AIMD distribution                           319,84 € 

Notification of MDD distribution                            307,95 € 

Notification of a tailor-made manufacturer              152,73 € 

Notification of a class I manufacturer                      152,73 € 

Notification of a systems and kits manufacturer      152,73 € 

Notification of a steriliser                                         152,73 € 

Changes to AIMD notification                                 63,98 €  

Changes to MDD notification                                  61,60 €

Certificate of export  (for AIMD)                            63,98 €

Certificate of export (for MDD)                               61,60 € 

 

All payments should be made to the account of the Federal Agency for Medicines and Health Products (FAMHP), shown below :

Account number N: 679-0021942-20

Swift Code or BIC :PCHQBEBB

IBAN code :BE28 6790 0219 4220

Last updated on 06/01/2016