Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook
Call Us Now:
+44 2080667260 sales@omcmedical.com

Morocco

Home
Morocco

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).

 

Want to know more about this registration process?

Schedule a Meeting