Master Medical Devices Registration United Arab Emirates
Be the expert of placing medical devices in the highly dynamic market of the United Arab Emirates, the business hub
Updated on Sep, 2023
Language - English
Course Description
In this course, I will take you through an interesting journey towards the highly dynamic market in the middle east region, we will fly together to the business hub of the middle east region, we will travel to the United Arab Emirates, we will go to Dubai and learn everything about medical devices placing in this highly interesting market.
This course will lead you from the start to the end of the process of placing medical devices in the market of the United Arab Emirates, we will explore together all aspects related to the regulatory activities and tools that help us to place our medical devices in such dynamic market.
This course is structured to act as a guide or a manual that you just have to follow step by step that will lead you smoothly towards the whole process.
We will start with classification as usual basic backbone step towards any product registration in any country
we will go through the classification guidelines and match them with the 3 basic classes of the medical devices, either normal medical devices, in-vitro medical devices, active medical devices.
Then will move to the manufacturer, along with its proof of quality compliance, which is the ISO 13485, and then will explore together the different CE certificate approvals in Europe.
Then we will dive deeper into the medical devices Registration Guidance issued in 2011, and still valid till now.
We will stop at the flow chart of the whole process of medical device registration in the UAE.
And then we will use all these tools to build up our submission dossier, will go through the documents checklist, forms, templates, and prepare them.
We will explain the term"Pharmaceutical Like Dosage Forms" for high-risk classes of medical devices, and how to deal with such a situation.
And then will close the course with the renewal and its flow chart, in addition to the updated circulars issued by the Ministry of Health and Prevention of the United Arab Emirates.
I hope that you enjoyed the flight.
Goals
What will you learn in this course:
By the end of this course you will master medical devices registration in the United Arab Emirates
By the end of this course you will master all regulatory activities of medical devices in the United Arab Emirates
By the end of this course you will place medical devices in the business hub of the Middle East
By the end of this course you will place medical devices in the highly dynamic market of Dubai
Prerequisites
What are the prerequisites for this course?
Just laptop and willing to succeed
Just laptop and passion towards new markets expansion
Curriculum
Check out the detailed breakdown of what’s inside the course
Medical Devices Registration United Arab Emirates
13 Lectures
-
Introduction
13:59
13:59
-
Medical Devices Classification
23:09
23:09
-
Classification Rules and Documents
04:40
04:40
-
The Manufacture
09:35
09:35
-
Quality
23:45
23:45
-
Marketing Authorisation
23:45
23:45
-
MD Registration Guidelines
22:15
22:15
-
Site Dossier
07:41
07:41
-
Registration Checklist
17:27
17:27
-
Summary of Registration
16:33
16:33
-
The Renewal
07:47
07:47
-
The Forms
18:30
18:30
-
Renewal&Closing
09:22
09:22
Instructor Details
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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