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 ClassificationDescriptionExamplesRisk Level
Class ISimple with history of safe useSimple surgical instruments, tongue depressorLow
Class II a relatively low risk to the human bodyDigestive catheters, infusion pumps, and powered wheelchairsLow - Moderate
Class II bRelatively high risk to the human bodyDialyzers, and orthopaedic implantsHigh - Moderate
Class IIIDevices that may endanger the Patient's lifeCoronary stentsHigh
Premarket Approval Process
Class IClass II aClass II bClass 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
ValidityThree Years
Postmarket Surveillance  Infringement to the law will result in punishment of imprisonment and a fine.
LanguageAll documents must be translated into either French or Arabic
Expected TimeNo official registration timeline. Import licence issued in 30 days.
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