General country-specific regulatory information is provided on this page for medical device registration and approval in Tunisia.
We review our Regulatory Information frequently; please check back often for updates
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.
For detailed device-specific compliance information for each market, including Tunisia, to expedite the preparation of your medical device or IVD registration application.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
