In this section we will go deeper into the regulatory system, with actual submissions with the details of the documents, focusing on what is special with MOH Egypt 

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

In this section we will participate the actual technical dossier to prepare it

In this section we will cover the registration process of the high-risk classes of medical devices, and combined products that could be classified as pharmaceuticals, all submitted with MOH Egypt through CAPA

In this section we will practice the actual dossier preparation

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 the copies required for NODCAR analysis

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

Please keep an eye on the updates , this is the key of success in regulatory affairs

Master Egypt’s MEDEVIC Platform: From Dossier Preparation to Medical Device Approval

Step into the world of Egyptian medical device registration and unlock the full potential of the MEDEVIC online submission platform! This course is your complete guide to preparing, submitting, and managing medical device dossiers electronically, giving you the confidence to navigate the regulatory process efficiently.

Whether you’re a Regulatory Affairs professional, Quality Manager, or Compliance Specialist, you’ll gain hands-on skills to streamline submissions, avoid common pitfalls, and accelerate approvals.

What You’ll Learn:

• Explore the MEDEVIC platform and understand its submission workflow.

• Prepare complete and compliant medical device dossiers from start to finish.

• Navigate the actual electronic submission process step by step.

• Handle documentation, certificates, and regulatory forms like a pro.

• Learn practical tips to expedite approvals and reduce errors.

Master Medical Device Compliance in Egypt: NODCAR, GTIN & PV Updates

Step into the heart of Egypt’s medical device regulatory system and gain the expertise to navigate NODCAR analysis, GTIN implementation, and the latest pharmacovigilance (PV) declarations — all under the Egyptian Drug Authority (EDA). This course is designed for Regulatory Affairs professionals, Quality Managers, PV specialists, and business leaders who want to ensure full compliance while accelerating market access.

Egypt is a unique market with specific regulatory requirements, including NODCAR’s specialized analysis for high-risk devices, GTIN tracking for traceability, and updated PV obligations for medical device safety. Mastering these elements will position you as a go-to expert for medical device registration and post-market compliance in Egypt.

What You’ll Learn:

• Navigate NODCAR analysis requirements and understand the unique documentation process.

• Implement GTIN codes effectively and comply with Egypt’s traceability regulations.

• Manage new PV declarations for medical devices, ensuring safety compliance and reporting.

• Prepare and submit complete dossiers under EDA regulations.

• Handle renewals, post-market surveillance, and updates efficiently.

• Learn market-specific exceptions, enforcement practices, and practical strategies.