Medical Device Registration in

Morocco

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 

Registration Process

  • 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).

 

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