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.