AIMD

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).  (DOC, 164 Kb)

The distributor must give notification beforehand by means of a notification form (AIMD) (XLS, 30.5 Kb) and attach the list of products  (AIMD) (XLS, 16.5 Kb) .

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 for active implantable medical devices (AIMD) - AR 15/07/1997. (XLS, 22 Kb)

Contact :

Nathalie Demaret, Eddy Buys

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 / 81 17 
Fax : +32 (0)2 524 81 20

Email : meddev@afmps.be