Certificates and application procedure

To obtain the export certificate for medical devices you must complete the form "Certificate for a medical device (DOC, 208.5 Kb)" / "Certificado de dispositivo medico (DOC, 210.5 Kb)".

The completed form must be sent with the following documents proving the conformity of the product :

-         A declaration of conformity
-         a copy of the CE certificates 
-         if relevant, a copy of  the ISO 9000 and EN /ISO 13485 certificates

Two color copies must be sent by regular mail to the Health Products division.

Payment of :

-         58.86 EUR must be made per certificate requested for medical devices 
-         61.14 EUR must be made per certificate requested for active implantable medical devices 

The payments must be made to account number 679-0021942-20.

Contact :

Carine Bakwa

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 83 39
Fax : +32 (0)2 524 81 20

Email : meddev@afmps.be