Pharmaceutical establishment importing medical devices (regulated activity)

Activity contents

• Pharmaceutical establishment for the Importation of medical devices.
• A medical device is any device, instrument, equipment, material or product, with the exception of products of human origin, or other article used alone or in combination, including accessories and software involved in its operation, intended to be used in humans for medical purposes.
• Medical devices are also considered to be those used in in vitro diagnostics: products, reagents, materials, instruments and systems, their components and accessories, as well as sample containers, specifically intended to be used in vitro, alone or in combination, in the examination of a sample from the human body, in order to provide information concerning a physiological or pathological condition, proven or potential, or a congenital anomaly, to control therapeutic measures, or to determine the safety of a sample of elements from the human body or its compatibility with potential recipients (in accordance with the provisions of articles 212 and 213 of Law No. 18-11 of July 2, 2018, relating to health);
• Importation of computer equipment and various measuring devices necessary for the operation of medical devices.

Supervisory authority

MINISTRY IN CHARGE OF THE PHARMACEUTICAL INDUSTRY

Type of authorization: Approval

How to start this activity in Algeria

Official procedure, ordering of steps, and realistic timelines

1. Step 1: Obtain the licence from MINISTRY IN CHARGE OF THE PHARMACEUTICAL INDUSTRY

   The activity "Pharmaceutical establishment importing 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 importing medical devices (regulated activity)" can then start lawfully.

   3 to 7 days

Legal references

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

Frequently asked questions

Other codes in the same group

• Import of equipment and tools intended for the manufacture of orthopedic devices (regulated activity). (434102)
• Import of equipment and instruments used for the maintenance and assembly of medical devices (434103)
• Pharmaceutical establishment importing pharmaceutical products. (regulated activity) (434104)
• Import of parapharmaceutical, cosmetic and personal hygiene products. (434105)
• Import of products and equipment intended for cleaning and disinfection of hospitals (434106)
• Pharmaceutical establishment importing pharmaceutical products (regulated activity) (434201)
• Import of para-pharmaceutical products. (434202)
• Import of veterinary products (regulated activity). (434301)
• Import of equipment and materials intended for the manufacture of eyewear. (434401)
• Import of eyewear. (434501)
• Importation of medical eyewear and optical devices, instruments and articles. (434502)