REGULATORY AUTHORITY: Directorate of Medicine and Pharmacy “La Direction du Médicament et de la Pharmacie” (DMP)

CLASSIFICATION SYSTEM:

Medical Devices: I/Im/Is/IIa/IIb/III

IVDs: No Classification

TIMEFRAME:

Official Timeline

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)

New Registration

Medical Devices – USD 111

IVDs – USD 56

LOCAL FEES (Manufacturer)

N/A

LICENSE VALIDITY: 5 years for both medical devices and IVDs.

LICENSE TRANSFER: License transfer is possible for both medical devices and IVDs.

Other Middle East & North Africa Countries: Algeria,Bahrain,Egypt,Israel,Jordan,Kuwait,Lebanon,Oman,Palestine,Qatar,Saudi Arabia,Tunisia,United Arabic Emirates,Yemen