Certificates and application procedure
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 :
- 60.48 EUR must be made per certificate requested for medical devices
- 62.82 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.
Jonathan Raes (Fr)
Nadya Tavajjoh (Nl)
Federal Agency for Medicines and Health Products
Health Products Division
Place Victor Horta, 40 box 40
Email : email@example.com