Regulatory Authority
Direction de la Pharmacy et du Medicament (DPM).
Classification
I, IIa, IIb, III, IV
Quality System
ISO 13485:2016 o ISO 9001
Medical Devices are subject to registration.
Foreign manufacturers intending to market Medical Devices or custom-made devices in Algeria must appoint a Local Authorized Representative who will be responsible for submitting the documents required in the registration process to the DPM.
Applicant
Authorised Local Representative.
Labelling and documentation language
Documentation and labelling must be provided in Arabic and French.