Medical Device Registration and Approval in Morocco
General country-specific regulatory information is provided on this page for medical device registration and approval in Morocco. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Morocco, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and classification in Morocco
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.
Last updated on January 8, 2020
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