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Medical Device Registration Consultant

The legislative and regulatory provisions are subject to changes and updated by the institutions in charge in the Country they are referred to. The undersigned declines any responsibilities with regards to obsolete or inexact information contained in this document.


Regulatory authority:

Direction de la Pharmacy et du Medicament (DPM).

Classification:

The product classification is Class I, Class IIa, Class IIb and Class III like CE classification. The regulatory authority is called as Direction de la Pharmacy et du Medicament (DPM).

Quality System :

The quality system shall meet the requirements laid down in standard ISO13485 and ISO 9001,

Procedure:

Medical Devices are object of registration. Manufacturers with no local presence in Algeria must appoint a Local Authorized Representative that will be responsible for the registration process and the submission of the documentation at the DPM.

Applicant:

Authorized representative.