Algeria Medical Device Regulations

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
Premarket Approval Process
Class I Class II a Class II b Class III
Appoint a Local Authorized Representative (LAR) in Algeria
Submit required documents (see below) to DPM
If approved, DPM will grant registration.
List of Required Documents
  • Manufacturer information
    • Application
    • Information on distributor and LAR
    • Declaration of Conformity
    • CE or its equivalent
 
  • Product information
    • Instructions, label, description, risk class, clinical data, device composition, method of sterilization and mechanism of action (if applicable), warnings, materials in packaging, clinical data
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.