Master Medical Devices Registration in Egypt

person icon Zahra Hassan Sobhy

Master Medical Devices Registration in Egypt

Be the expert of medical devices registration in the market of Egypt

updated on icon Updated on Oct, 2023

language icon Language - English

person icon Zahra Hassan Sobhy

architecture icon Business,Industry,Medical Device Development

Lectures -9

Resources -7

Duration -1.5 hours


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Course Description

In n this course, we will explore together how can we place our medical devices in the highly potential market, huge bulky market, the 100 million population market of Egypt.

We will go back to the ancient pharaohs area and place our medical devices there

This would be a very interesting special journey, as the market of Egypt has its own dynamics

which requires close follow up to keep an eye on the updates, and also need close relation with your business partners there 

We will be the expert on medical devices registered with the MOH of Egypt

MOH of the republic of Egypt does not have an electronic system of handling regulatory activities, not yer adopted the eCTD system. that is why the MOH of Egypt considers only hard copies, and actual physical dossiers to be submitted personally through your local agent in Egypt with Egypt MOH through prior appointment.

In this unique trip, we will cover, the whole life cycle of medical devices starting from classification, passing by registration checklist, then the registration guidelines, and see how we can prepare these required documents, forms, let's practice the actual dossier preparation, then we will move to renewal, we will close the medical devices registration session with the general conditions as a sum-up.

Egypt has many exceptions regarding the requirements for either registration or analysis, so please pay attention to these exceptions as they are unique for the market of Egypt only.

The analysis part is so special here, as there is a special institution for the analysis, which is the NODCAR

which is physically not in the same place as the MOH as the case with all other health authorities

The NODCAR is so unique analysis institution with a unique long list of analysis documents 

So fasten your seat belt and lets' fly to 7000 years back, let's fly to the pharos

Who this course is for:

  • All Pharma industry professionals, regulatory affairs professionals, and those who deiced to start their career in the pharma industry


What will you learn in this course:

  • By the end of this course you will master medical devices registration in the bulky market of Egypt

  • Place your medical devices in the bulky market of Egypt

  • Master medical devices regulatory activities in Egypt


What are the prerequisites for this course?

  • Just laptop and willing to succeed

Master Medical Devices Registration in Egypt


Check out the detailed breakdown of what’s inside the course

Master Medical Devices Registration in Egypt
9 Lectures
  • play icon Introduction 18:55 18:55
  • play icon The Regulatory System 15:23 15:23
  • play icon Registration process 12:07 12:07
  • play icon The Technical File 08:18 08:18
  • play icon Registration of Class III Medical Devices 14:17 14:17
  • play icon The Actual Dossier 13:47 13:47
  • play icon NODCAR 10:22 10:22
  • play icon MOH Circulars 09:04 09:04
  • play icon The Updates 14:52 14:52

Instructor Details

Zahra Hassan Sobhy

Zahra Hassan Sobhy

This is Zahra Hassan, I'm a pharmacist, with almost 10 years of experience in the pharma industry, my experience is extended to cover the regulatory affairs field, which deals with registration and granting health authorities approval for health products, including medicines, medical devices, over the counter products "OTC", such as food supplements, and cosmetics as well.

This is in addition to the quality compliance, control, and assurance for these health products, and also ensuring product safety through pharmacovigilance activities.

I have been practicing all these professions for 10 years covering 20 countries, across the regions of the Middle East, Africa, Levant, and Turkey.

During my career journey, I gave myself lots of credits by postgraduates studies

Msc of pharmacovigilance Bordeaux university France

MBA, Chiffley buisneiss school , Australia

Dual Diploma of regulatory affairs "pharmaceutical and medical devices" RAP society, USA.

Certified lead auditor

currently enrolled in the Ph.D. program of pharmacovigilance Bordeaux university France

Despite the fact that postgraduate studies for sure will add to the profile, but the practice is something else, in the begging of my career journey I was chasing professionals asking for private lessons after work to gain practical experience from them, and it was not for free, I used to make this deal with many professionals as I can to get as much diverse experience that I can gain, in addition, I used to follow national and international pharma industry events attending, then participating from my own pocket. This simply happens when you follow your passion.

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