Certificates and application procedure

To obtain the export certificate for medical devices you must complete the form "Certificate for a medical device (DOC, 1.97 MB)" / "Certificado de dispositivo medico (DOC, 1.97 MB)".

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

Please follow the instructions mentioned on the following document. The document is only available in French (DOC, 249 Kb) or Dutch (DOC, 255.5 Kb).

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

Please mention the notification number for each medical device in case of an export of medical devices of Class I.

Payment of :

-         61.02 EUR must be made per certificate requested for medical devices 
-         63.38 EUR must be made per certificate requested for active implantable medical devices 

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

The deadline of treatment is of 5 weeks. 

Contact :

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

Email : meddev@afmps.be

Last updated on 28 February 2014

5-year celebrations at famhp!

On this occasion the famhp has adopted a new visual identity and a new logo.

read more

PIL and SPC
of a medicine

(PIL: patient information leaflet SPC: summary of product characteristics)

Newsletter

Subscribe to our newsletter

Your e-mail