Training offer - Egypt

Mastering Egyptian Medical Device Regulations: EDA Compliance, Registration & Market Access

Morning Session: The EDA Regulatory Architecture (4 Hours)

Module 1: The Egyptian Regulatory Landscape (1h)

  • Role of the EDA (Central Administration of Medical Devices) and Law 151/2019.

  • Understanding the MeDevice portal: User accounts and digital submission workflows.

  • Risk Classification (Class I, IIa, IIb, III) aligned with IMDRF/EU MDR standards.

Module 2: Local Representation & Establishment (1h)

  • The Egyptian Registration Holder (ERH) vs. Scientific Office models.

  • Legal requirements for the local agent and the Technical Director’s responsibilities.

  • Site registration requirements for foreign manufacturers.

Module 3: Registration Pathways & Technical Dossiers (2h)

  • Fast-Track vs. Normal Track: Leveraging CE MDR/IVDR or FDA approvals for 3-month clearances
  • Compiling the CSDT (Common Submission Dossier Template)
  • Essential documents: Legalized FSC, ISO 13485, and Declaration of Conformity.
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Afternoon Session: Importation, Vigilance & Market Strategy (4 Hours)

Module 4: Import Approvals & Customs Release (1h)

  • The Technical Visa: Securing the « Import Approval » for each shipment.

  • Managing pro-forma invoices and batch-specific permits on the EDA portal.

  • Interaction with the National Laboratory (NODCAR/NORCB) for testing and release.

Module 5: Labeling & Arabic Language Compliance (1h)

  • Specific labeling requirements for « Home Use » (Arabic mandatory) vs. « Professional Use » (English accepted).

  • Managing UDI (Unique Device Identification) requirements in Egypt

Module 6: The New 2025 Vigilance & PMS System (1h)

    • Deep dive into the MDSU (Medical Device Safety Unit) requirements.

    • Mandatory reporting timelines for adverse events (2 to 30 days).

    • Submitting Periodic Safety Update Reports (PSUR) and Post-Market Surveillance (PMS) plans.

Module 7: Public Tenders & UPA Strategy (0.5h)

  • The role of the Unified Procurement Authority (UPA) in centralized purchasing
  • How to register products specifically for national healthcare tenders.
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Module 8: Final Workshop & Q&A (0.5h)

Reviewing common « Deficiency Letters » from the EDA and how to respond.

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.

Unlock the Egyptian Healthcare Market: Book Your Compliance Training

From EDA registration to UPA tender success, master every step of the Egyptian regulatory journey. Join our expert-led session to ensure your medical devices reach Egypt’s 100+ million patients without delay.

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