Authorized Representative for Medical Devices – Morocco
To market medical devices in Morocco, foreign manufacturers must comply with local regulatory requirements and appoint a local Authorized Representative. Registration is mandatory, and a Registration Certificate issued by the Medical Device Advisory Committee is required before any medical device can be legally commercialised in the Moroccan market.
A qualified Authorized Representative acts as your local compliance partner, guiding you through registration procedures, documentation requirements, and ongoing regulatory obligations, ensuring your medical devices meet Moroccan standards and reach the market efficiently and legally.
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