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Manufacturing of medical devices (regulated activity)

Regulated activity · CNRC 104226 · Goods Production

Activity contents

  • Pharmaceutical establishment manufacturing medical devices.
  • The 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 invitro diagnosis: 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 samples from the human body, in order to provide information concerning a physiological or pathological state, 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).

Authorized accessory activities

  • Distribution of products defined in the content of the activity, intended for wholesalers and communities.

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 "Manufacturing 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 "Manufacturing of 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

How do I start the activity "Manufacturing of medical devices (regulated activity)" in Algeria?

"Manufacturing of medical devices (regulated activity)" is regulated: first obtain the official licence from MINISTRY IN CHARGE OF THE PHARMACEUTICAL INDUSTRY, then incorporate (SARL/EURL usually required) at CNRC, and finish with tax registrations. UpGrowth Connect handles licence + turn-key incorporation.

How much does it cost to incorporate for code 104226?

For a regulated activity like Manufacturing of medical devices (regulated activity): 75 000 DZD (sole proprietorship) or about 118 610 DZD (SARL/EURL excluding share capital), plus licence cost (varies per MINISTRY IN CHARGE OF THE PHARMACEUTICAL INDUSTRY). UpGrowth Connect: 60 000 DZD ex-tax + State fees.

Is the ANAE auto-entrepreneur regime allowed for Manufacturing of medical devices (regulated activity)?

ANAE is reserved for individual services, capped at 5M DZD/year. For "Manufacturing of medical devices (regulated activity)", verify eligibility via UpGrowth's ANAE tool or with MINISTRY IN CHARGE OF THE PHARMACEUTICAL INDUSTRY.

Which supervisory authority oversees code 104226?

The official supervisory authority for Manufacturing of medical devices (regulated activity) is MINISTRY IN CHARGE OF THE PHARMACEUTICAL INDUSTRY. This body is responsible for regulation, accreditation and oversight of the activity.

Is the activity "Manufacturing of medical devices (regulated activity)" regulated in Algeria?

Yes, Manufacturing of medical devices (regulated activity) (CNRC code 104226) is classified REGULATED. A prior licence from MINISTRY IN CHARGE OF THE PHARMACEUTICAL INDUSTRY is mandatory before CNRC registration.

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