The distribution of active implantable medical devices is regulated by the Royal Decree dated 15/07/1997 (French version), modified by the Royal Decree dated 10/12/2002 (French version) and by the Royal Decree dated 21/01/2009 (French version) (+1 appendix). 

The distributor must give notification beforehand by means of a notification form (AIMD) and attach the list of products  (AIMD) .

If the file is complete a receipt is sent and the registration number is communicated to the applicant as proof of the notification .

List of distributors and exporters recognised on 19/11/2014 for active implantable medical devices (AIMD) - AR 15/07/1997.

Contact :

Federal Agency for Medicines and Health Products 
Health Products Division 
Eurostation II
Place Victor Horta, 40 box 40
1060 Brussels

Fax : +32 (0)2 524 81 20

Email :

Last updated on 17/03/2021