REGULATORY AUTHORITY: Directorate of Medicine and Pharmacy “La Direction du Médicament et de la Pharmacie” (DMP)
Medical Devices: I/Im/Is/IIa/IIb/III
IVDs: No Classification
Medical Device New Registration – 120 days
IVD New Registration – maximum 12 months
Actual Timeline (based on experience)
Medical Device New Registration – 90 days
IVD New Registration – 90 days
AUTHORIZED REPRESENTATIVE: A foreign manufacturer must appoint a local company to become their authorized representative.
SPECIAL REQUIREMENTS: The local technical evaluation is required only for IVDs.
LOCAL FEES (New Application)
Medical Devices – USD 111
IVDs – USD 56
LOCAL FEES (Manufacturer)
LICENSE VALIDITY: 5 years for both medical devices and IVDs.
LICENSE TRANSFER: License transfer is possible for both medical devices and IVDs.