Ministry of Health

Moroccan Ministry of Health (MOH)

Regulatory Authority

Direction du Médicament et de la Pharmacie (DMP)

Medical Device Regulation

EU MDR 2017/745

Official Language

Arabic, Standard Moroccan Berber

Classification

I/Im/Is/IIa/IIb/III

Medical Device Registration in Morocco

• Determine the device classification.
• Foreign Manufacturers must appoint a Local Authorized Representative.
• A registration certificate is issued by the Medical Device Advisory Committee.
• Prepare the registration certificate and submit to DMP
• Once approved, the device can be now marketed in Morocco.

Documents Required

• FSC and QMS certificates
• A commercial invoice which should fully describe the goods in French
• CE certificate
• Other regulatory approvals
• Payments are made through bank-to-bank irrevocable letters of credit
• Technical documentation
• Labels, IFUs or User Manuals

Applicable QMS

ISO 13485

Registration Timeline

90 – 120 days

Authorized Representative

Yes

License Validity

5 years

Special Notes

• Label and instructions for use must be provided in French or Arabic.
• Morocco generally recognizes the European (CE marking) and US certification (FDA).