All Medical Devices must obtain the Marketing Authorization (AMC) issued by the DPM.
Manufacturers without local presence in Tunisia must appoint a Local Authorized Representative also acting as an importer and responsible for submitting all the documentation required by the procedure to the Competent Authority.
Thanks to agreements with the European Union, Medical Devices that have CE marking enjoy a faster registration.
Local Authorized Representative.
Labelling and documentation language
Documentation and label must be provided in French or Arabic.
The Local Authorized Representative will be the owner of the obtained license.