Pharmaceutical establishment for the export of medical devices (regulated activity)

Activity contents

• Pharmaceutical establishment to export medical devices.
• The medical device is any apparatus, instrument, equipment, material or product, except products of human origin, or other article used alone or in combination, including accessories and software used in its operation, for use in humans for medical purposes.
• Products, reagents, materials, instruments and systems, their components and accessories, as well as containers for samples, intended specifically for use in vitro, alone or in combination, in the examination of samples from the human body, shall also be considered medical devices, in order to provide information concerning a physiological or pathological state, known or potential, or a congenital anomaly, to control therapeutic measures, or to determine the safety or compatibility of a collection of human body elements
• With potential recipients (in accordance with the provisions of Articles 212 and 213 of Act No. 18-11 of 2 July 2018 on health).
• Purchase and storage of locally produced or imported medical supplies for export.

Supervisory authority

DEPARTMENT OF THE PHARMACEUTICAL INDUSTRY

Type of authorization: Agreement

How to start this activity in Algeria

Official procedure, ordering of steps, and realistic timelines

1. Step 1: Obtain the licence from DEPARTMENT OF THE PHARMACEUTICAL INDUSTRY

   The activity "Pharmaceutical establishment for the export of medical devices (regulated activity)" is regulated. You must first build an accreditation file with the supervisory authority (articles, qualification proof, premises eligibility) before any CNRC registration.

   2 to 6 weeks

2. Step 2: Company incorporation (LLC, single-member LLC or sole proprietorship)

   Once you hold the licence, sign the articles at the notary, declare the share capital, then request the company name + Trade Register at CNRC. For a heavy licence, a SARL/EURL is usually required over the auto-entrepreneur regime.

   7 to 10 days

3. Step 3: Tax and social registrations

   With your trade register in hand, obtain the NIF (tax ID), NIS (social security ID for the manager), CNAS affiliation for employees, and the tax card. Your activity "Pharmaceutical establishment for the export of medical devices (regulated activity)" can then start lawfully.

   3 to 7 days

Legal references

• Executive Decree No. 21-82 of 23 February 2021, Relating to pharmaceutical establishments and the conditions for their approval.

Frequently asked questions