Training offer - Algeria

Mastering Algerian Medical Device Regulations: Compliance, Homologation & Market Entry

Morning Session: Strategic Framework & Establishment Licensing (3.5 Hours)

Module 1: The Algerian Regulatory Ecosystem (1h)

  • The role of the ANPP and the Ministry of Industry and Pharmaceutical Production.

  • Overview of the legal framework: From Law 18-11 to the latest 2025 Ministerial Decrees.

  • Medical Device Classification and IVD specifics

Module 2: Licensing of Pharmaceutical & Medtech Establishments (1h)

  • New 2025 Requirements: Understanding latest Decrees regarding import and wholesale distribution licenses.
  • The role and responsibility of the Technical Director Pharmacist
  • Facility requirements and ANPP pre-license inspections.

Module 3: The Registration Dossier (Homologation) (1h)

  • Technical File requirements

  • Administrative documentation

  • Pricing files and economic evaluation criteria in Algeria.

Afternoon Session: Digitalization, Serialization & Market Access (3.5 Hours)

Module 4: 2025 Serialization & Traceability Mandates (1 h)

  • Deep dive into latest Decrees : Mandatory Data Matrix and GS1-compliant coding for health products.

  • Integration with the National Track and Trace System.

  • Labeling and Packaging: Bilingual (Arabic/French) compliance.

Module 5: Importation Workflow & Technical Visas (1h)

  • Securing the « Visa Technique » for each shipment.

  • Customs clearance procedures and interaction with the LNCPP (National Laboratory).

  • Managing renewals and substantial modifications to the homologation.

Module 6: Materiovigilance & Case Study (1h)

  • Setting up a local vigilance system.
  • Reporting adverse events to the ANPP.
  • Workshop: Avoiding common pitfalls that lead to dossier rejection.
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Module 7 : Managing the Annual Importation Program (1h)

  • Securing the « Visa Technique » for each shipment.

  • Customs clearance procedures and interaction with the LNCPP (National Laboratory).

  • Managing renewals and substantial modifications to the registration.

Flexible Training Formats

To better serve your needs, Simon Medtech Solutions offers this Moroccan regulatory training in three distinct formats:

A multicultural office team engages in a collaborative brainstorming session around a conference table.

On site

In-Company : We bring the expertise to your office. A customized session tailored specifically to your company’s product portfolio and team requirements.

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Face to Face

Public Workshops : Join our scheduled sessions in premium venues to network with other industry professionals while learning.

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Video conference

Video Conference (Live Online): A fully interactive digital classroom experience, perfect for international teams or those preferring the convenience of remote learning.

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