Training offer - Morocco

Mastering Moroccan Medical Device & IVD Regulations: Compliance, Registration & Market Access

Morning Session: Legal Framework & Establishment Requirements (3.5 Hours)

Module 1: Introduction to the Regulatory Landscape (1h)

  • Understanding Law 84-12 and its implementing decrees.

  • Presentation of the AMMPS and its role.

  • Nomenclature and Classification of MDs and IVDs

Module 2: The Medical Device Establishment (1h)

  • Pre-requisites for opening: Facilities, storage, and the Responsible Pharmacist.

  • The establishment declaration procedure.

  • Good Distribution and Storage Practices (GDSP) compliance.

Module 3: Preparing the Registration Dossier (1.5h)

  • Administrative dossier structure (FSC, ISO 13485, CE Mark, FDA Approval…).

  • Technical dossier deep-dive: Safety and performance requirements.

  • Labeling and Instructions for Use (IFU): Specific Moroccan linguistic and graphic rules.

Afternoon Session: Digital Procedures & Post-Market Obligations (3.5 Hours)

Module 4: Mastering Digital Platforms (1.5h)

  • Practical Workshop: Navigating the DMP online portal.
  • Electronic Filing: Managing forms and uploading supporting documents
  • Tracking queries and managing « Requests for Information » (RFI).
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Module 5: Importation & Post-Market Surveillance (1h)

  • The Registration Certificate and import authorizations
  • Materiovigilance: Obligations for reporting adverse incidents
  • Managing technical variations and renewals (5-year validity).
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Module 6: Q&A Session & Case Studies (1h)

  • Analysis of real-world dossiers and common mistakes to avoid.
  • Final assessment and knowledge validation quiz.
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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.

What Simon Medtech Solutions Brings to This Training ?

  • Field Expertise: Training delivered by consultants actively managing submissions in the Moroccan market.

  • Practical Tools: Provision of compliance checklists and dossier templates.

  • Support: Post-training audit options for your specific registration files.

Secure Your Market Access: Book Your Expert Training Today

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