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.

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