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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.
Last updated on April 12th, 2022.
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.
Other Middle East & North Africa Countries: Algeria,Bahrain,Egypt,Israel,Jordan,Kuwait,Lebanon,Oman,Palestine,Qatar,Saudi Arabia,Tunisia,United Arabic Emirates,Yemen
For detailed device-specific compliance information for each market, including Morocco, to expedite the preparation of your medical device or IVD registration application.
Any Questions?
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