REGULATORY AUTHORITY:
Medical devices and in vitro diagnostics (IVDs) in Morocco are regulated by the Moroccan Agency for Medicines and Health Products (AMMPS), which has replaced the Directorate of Medicine and Pharmacy (DMP).
AMMPS is responsible for the regulation and oversight of medicines, medical devices, cosmetics, and infant care products.
CLASSIFICATION SYSTEM:
- Medical Devices: Class I (I / Is / Im), Class IIa, Class IIb, Class III.
- IVDs: No risk-based classification. All IVDs are treated under the same regulatory pathway.
TIMEFRAME:
Medical Devices: Official timeline: up to 120 days for new registration (all classes).
IVDs: Official timeline: up to 12 months.
LICENSE VALIDITY: Registration certificates are valid for 5 years and are renewable.
LOCAL FEES (New Application):
- Medical Devices:
New registration: 1000 MAD (~USD 111)
Renewal fee: 1000 MAD (~USD 111) - IVDs:
New registration: 500 MAD (~USD 56)
Renewal fee: 500 MAD (~USD 56)
AUTHORIZED REPRESENTATIVE / LICENSE HOLDER:
A local importer must act as the License Holder (LH) in Morocco. Foreign manufacturers cannot hold registrations directly.
Multiple importers are allowed; however, each importer must hold its own registration certificate for the same product.
LICENSE TRANSFER:
License transfer is possible for both medical devices and IVDs.
ADDITIONAL INFORMATION:
- Registration is mandatory for both medical devices and IVDs unless the product qualifies for a specific authorization or exemption (e.g., samples, research use, custom-made devices, refurbished devices for export).
- Labeling must be provided in Arabic or French for products intended for the general public; English is accepted for professional-use devices.
Other Middle East & North Africa Countries: Algeria,Bahrain,Egypt,Israel,Jordan,Kuwait,Lebanon,Oman,Palestine,Qatar,Saudi Arabia,Tunisia,United Arabic Emirates,Yemen
