Medical Device Registration in
Ministry of Health
Medical Device Regulation
EU MDR 2017/745
Arabic, Standard Moroccan Berber
- 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.
- 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
90 – 120 days
- Label and instructions for use must be provided in French or Arabic.
- Morocco generally recognizes the European (CE marking) and US certification (FDA).