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.
Please mention the notification number for each medical device in case of an export of medical devices of Class I.
Payment of :
- 60.95 EUR must be made per certificate requested for medical devices
- 63.31 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.
Federal Agency for Medicines and Health Products
Health Products Division
Place Victor Horta, 40 box 40
Email : firstname.lastname@example.org