Agency
All medical devices are regulated by the Directorate of Pharmacy - Direction de la Pharmacy et du Medicament (DPM) under the Ministry of Health and Population (MOHP)
Medical Device Definition
Any equipment, device, instrument or product, with the exception of human origin products or other article used alone or in combination, including accessories or software interfering in its functioning for use in humans for purposes: diagnosis, prevention, monitoring, treatment or alleviation of disease or compensation for an injury or handicap; study, replacement or modification the anatomy or of a physiological process; control of medically assisted procreation Loi n° 08-13, Art. 6
Classification of Medical Device
International Classification |
Description |
Examples |
Risk Level |
Class I |
Simple with history of safe use |
Simple surgical instruments, tongue depressor |
Low |
Class II a |
relatively low risk to the human body |
Digestive catheters, infusion pumps, and powered wheelchairs |
Low - Moderate |
Class II b |
Relatively high risk to the human body |
Dialyzers, and orthopaedic implants |
High - Moderate |
Class III |
Devices that may endanger the
Patient's life |
Coronary stents |
High |
Postmarket Approval Process
Validity |
Three Years |
Postmarket Surveillance |
Infringement to the law will result in punishment of imprisonment and a fine. |
Language |
All documents must be translated into either French or Arabic |
Expected Time |
No official registration timeline. Import licence issued in 30 days. |