MEDICAL DEVICE REGISTRATION AND APPROVAL IN Morocco

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 update: December 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 TRANSFERLicense 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

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