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 TRANSFERLicense transfer is possible for both medical devices and IVDs.  

Last updated on January 8, 2020

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