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
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
Between 1 and 2 months.
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).