Tunisia

The information on this page is valid and current as of December 2015. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer


Regulatory Authority:
Direction de la Pharmacie et du Medicament (DPM).

Classification:
I, IIa, IIb, III.

Procedure:
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.

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Applicant:
Local Authorized Representative.

Labeling and documentation language:
Documentation and label must be provided in French or Arabic.

Useful information:
The Local Authorized Representative will be the owner of the obtained license.

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