Master Medical Device Registration in Egypt

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About Course

Learn how to confidently register pharmaceutical products in Egypt through this practical, industry-focused course covering the complete Egyptian pharmaceutical registration process.

This comprehensive course provides a step-by-step guide to navigating the requirements of the Egyptian Drug Authority and the Egyptian Ministry of Health, including registration pathways, NODCAR analysis, pricing strategies, dossier preparation, pharmacovigilance requirements, renewals, and regulatory exceptions.

Designed for Regulatory Affairs professionals, pharmaceutical companies, manufacturers, importers, and healthcare business leaders, this course simplifies complex Egyptian regulations into a practical, easy-to-understand learning experience focused on real-world applications and successful market access.

 

This course is designed to provide practical, industry-focused knowledge for professionals aiming to succeed in medical device registration in Egypt and confidently navigate the evolving requirements of the Egyptian healthcare market.

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What Will You Learn?

  • Introduction to the Egyptian Drug Authority and Egypt’s medical device regulatory framework
  • Step-by-step guidance for the medical device registration process in Egypt
  • Learn how to prepare a complete technical file and regulatory dossier aligned with EDA requirements
  • Gain advanced insights into Class III medical device registration and high-risk device compliance strategies
  • Practice with real-world dossier preparation and submission examples
  • Understand and navigate the NODCAR analysis process, one of Egypt’s unique regulatory requirements
  • Stay updated with the latest EDA regulations, market exceptions, and regulatory updates
  • Understand the complete medical device lifecycle management process, from classification and registration to renewals and post-market compliance
  • Strengthen your expertise in medical device Regulatory Affairs, Egyptian market access, and compliance systems

Course Content

Module 1: Introduction
Let's get introduced and master EDA

  • Introduction
    18:23

Module 2:The Regulatory System
In this section we will go deeper to the regulatory system , with actual submissions with the details of the documents, focusing on what is special with MOH Egypt

Module 3:Registration process
In this section we will prepare the medical devices submission dossiers that should go through either DPPC or CAPA as per the class of the medical device

Module 4:The Technical File
In this section we will participate the actual technical dossier to prepare it

Module 5: Registration of Class III Medical Devices
In this section we will cover the registration process of the high risk classes medical devices , combined products, could be classified as pharmaceuticals , all submitted with MOH Egypt through CAPA

Module 6: The Actual Dossier
In this section we will practice the actual dossier preparation

Module 7: NODCAR
In this section we will move from MOH of Egypt to the NODCAR for the sample analysis associated with the registration attaching the list of documents along with its copies required for NODCAR analysis

Module 8: MOH Circulars
In this closing session we will go through some circulars to keep up to date with the changes in this huge dynamic bulky market

Module 9: The Medevic Platform
The Medevic Platform for online submission

Module 10: NODCAR Analysis
In this section you will mastre the NODCAR nalsyis , requirements and Appliaction, plus GTIN enforcement , and the 3 new PV declarations required for the PV practicing of any medical device

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