Fees based on the turnover made in Belgium and payments

Fees based on the turnover made in Belgium

Article 224 of the law dated 12th August 2000 (French version) ammended in 2008 (DOC, 70.5 Kb), concerning social, budgetary and other arrangements, indicates that a fee of 0.05% of turnover made on the Belgian market is liable from distributors who have delivered medical devices to end users or to people responsible for delivery.

The declaration of turnover (DOC, 203 Kb) must be made before 30th June of the following financial year. The fee must be transferred to the Federal agency for medicines and Health products account, mentioning: fee Meddev CA ****.  The 4* refer to the year when the turnover was made.

More detailed information can be found in circular 401b  (PDF, 22.88 Kb) and circular 408 (PDF, 32.93 Kb) .

The address, telephone number, fax number, e-mail address and account number mentioned in these circulars, which date from 2001, are no longer correct. The new details are shown at the bottom of this page.

Payments concerning medical devices

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

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

Notification of an AIMD clinical evaluation                2292.29 € 

Notification of an MDD clinical evaluation                 2189.31 € 

Notification of AIMD distribution                              305.64 €

Notification of MDD distribution                               294.27 € 

Notification of a tailor-made manufacturer               145.95 €

Notification of a class I manufacturer                      145.95 €

Notification of a systems and kits manufacturer       145.95 €

Notification of a steriliser                                       145.95 €  

Changes to AIMD notification                                 61.14 €  

Changes to MDD notification                                  58.86 €

Certificate of export  (for AIMD)                             61.14 €

Certificate of export (for MDD)                               58.86 € 

Copy of document AIMD                                        15.28 € + 0.45 €/sheet

Copy of document MDD                                         14.70 €

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

Bank : Poste financière

Chaussée d'Anvers, 59

1100 Bruxelles

Contact:

Nathalie Demaret

Federal Agency for Medicines and Health Products

Health Products Division 
Eurostation II
Place Victor Horta, 40 box 40
1060 Brussels

Tel. : +32 (0)2 524 81 18
Fax : +32 (0)2 524 81 20

Email : meddev@afmps.be