Algeria Medical Device Registrations

Regulatory Authority:  Directorate of Pharmacy – Direction de la Pharmacy et du Medicament (DPM)

Link for MoH: https://ghdx.healthdata.org/organizations/ministry-health-and-population-algeria 

Local Listing or Registration: Yes, Local listing is required.

Local Regulation: Article 7 – Executive Decree No. 11-380 (dt. Nov. 21, 2011)

Overview of Algeria Medical Device Regulations

Algeria’s medical device regulations are governed primarily by the Ministry of Health, Population, and Hospital Reform (Ministère de la Santé, de la Population et de la Réforme Hospitalière, MSPRH). The regulations aim to ensure the safety, efficacy, and quality of medical devices marketed and used within the country.

Medical Devices Classes

• I class
• IIa class medical devices,
• IIb class medical devices,
• III class medical devices,

Medical Device Registration in Algeria

Devices falling in the above classes has to be registered at the National Register of Medical Devices before placing in Algerian market.

Who should do the registration?

• Manufacturer,
• manufacturer’s representative in the Republic of Algeria,
• wholesaler(Authorized by Manufacturer).

Registration Timeline

No defined registration timeline. Import License is issued in 30 days

Registration certificate validity

3 years from the date of its issuance.