Medical Device Registration and Approval in Tunisia

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

Medical Device Regulations and Classification in Tunisia

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.