Regulatory authority

General Directorate of Pharmacy and Health Equipment


Classification

I, IIa, IIb, III, IV.


Quality system

ISO 13485 or ISO 9001


Procedure

  • 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

Authorized Local Representative


Labeling and documentation language

Documentation and labeling must be provided in Arabic and French.