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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.
Last updated on November 24th, 2021.
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.
For detailed device-specific compliance information for each market, including Tunisia, to expedite the preparation of your medical device or IVD registration application.
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