Medical Devices are subject to registration.

Foreign Manufacturers must appoint a Local Authorized Representative.

In order to commercialize a medical device in the local market, A Registration certificate issued by the Medical Device Advisory Committee is needed in order to market Medical Devices in Morocco.

APPLICANT

• Local Authorized Representative.

TIMEFRAME AND FEES

• Official Timeline
• Medical Device New Registration – 120 days
• IVD New Registration – maximum 12 months
• New Registration
• Medical Devices – USD 111
• IVDs – USD 56

LABELLING AND DOCUMENTATION LANGUAGE

• Label and instructions for use must be provided in French or Arabic.

USEFUL INFORMATION

Morocco generally recognizes the European (CE marking) and US certification (FDA).

REGULATORY AUTHORITY

• Direction du Médicament et de la Pharmacie (DMP)

CLASSIFICATION

• Medical Devices: I, Im, Is, IIa, IIb, III

In-vitro diagnostic medical reagents: none