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: Medical devices are regulated through the Bureau of Medical Devices, a division of the Department of Medicine and Pharmacy.

CLASSIFICATION SYSTEM: There is no special requirement for a specific classification system or previous foreign marketing approvals. However, certain documents, such as CFS and QMS certificates, may be required. In the case of pre-used equipment, it is also required to present FDA clearance.

TIMEFRAME: Licenses issued in Morocco are valid for five years.

AUTHORIZED REPRESENTATIVE: A local representative is required.

Last updated on March 17 2015.

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