Tunisia
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

REGULATORY AUTHORITY
: The Ministry of Public Health regulates the importation and registration of medical devices in Tunisia through the Directorate of Pharmacy and Pharmaceuticals (DPM).

CLASSIFICATION SYSTEM: There is no official classification system for medical devices. All imported products are classified by the Department of Commerce for technical inspection into categories A, B, and C.

TIMEFRAME: The approval process is completed in an average of thirty days.

LICENSE VALIDITY: An import license expires after one year, while the authorization to market a medical device expires after five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

Last updated on March 17 2015.



Interested in obtaining fast market approval for your medical device or IVD in Tunisia? REQUEST A FREE QUOTE>

For more information on registration in Tunisia, check out the following articles on our blog:
Country at a Glance: Tunisia
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