: The Ministry of Public Health regulates the importation and registration of medical devices in Tunisia through the Directorate of Pharmacy and Pharmaceuticals (DPM).
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.
An authorized representative is required.
Last updated on March 17 2015.
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For more information on registration in Tunisia, check out the following articles on our blog: Country at a Glance: Tunisia