Master Medical Device Registration In Saudi Arabia
Master medical devices registration in Saudi Arabia market , the biggest market in the GCC , the highest ROI market
Updated on Sep, 2023
Language - English
Master medical devices registration in the most important and biggest market ever in the GCC region, the market of Sudi Arabia, this market could be missed by any pharmaceutical or healthcare company, all the pharma industry professionals understand very well the weight of this market, how huge it is, and what is the expected revenue out of it.
This course will equip you with two powerful tools to invade the pharma industry, as a regulatory affairs professional you are responsible for bringing up to 80% if not 90% of the company revenue from only one market in the GCC region in one hand while in your other hand you are dealing with the second powerful tool of the medical devices, as medical devices registration time frame is shorter than the pharmaceuticals, ist is almost half the time frame of the pharmaceuticals.
To register a medical device you will need only 6 months, 3 months for variation, and 2 to 1 month only for renewal.
So from a business point of view, you can place your product in the market quite faster and start earning your revenue quite fast also, moreover, the medical devices world is highly dynamic and innovative, compared to the pharmaceuticals, lots of innovations different versions of the same medical device could be played within the potential market of the KSA.
Daer pharma industry future professionals, let us start our interesting journey towards medical device registration in KSA, we will travel together Saudia Arabia, meet the health authority there "SFDA", and explore its requirements for registration, renewal, and variations, let us get our MDMA and place our products there.
In this course, we will cover all topics related to medical devices in the KSA, starting from the requirements, interim regulations, classification, verification, and special conditions.
Then we will go deeper to see the actual forms, and templates as usual I keep the theme of the Pharma Academy that it comes to you "From Practice", and prepare the submission dossier together, and ensure its verification, budling /grouping criteria of the medical devices in only one MDMA application, and interact with the actual SFDA gateway for MDMA submission.
and we will end our journey, by landing the department of custom clearance, tracking /tracing system, barcoding, 2DMatrix for all the shipments planned for KSA market importation.
And finally, congratulations to you for mastering medical device registration in the KSA market, and see you soon in the pharma industry my dear colleagues.
What will you learn in this course:
By the end of this course you will master medical devices registration in Saudi Arabia, the biggest GCC market ever
Medical Devices Registration in Saudi Arabia
Medical Devices Registration in KSA
Medical Devices Registration in the biggest market in the GCC
Medical Devices Registration in the highest ROI market in the GCC
What are the prerequisites for this course?
Just laptop and willing to succeed
Check out the detailed breakdown of what’s inside the course
Master Medical Device Registration In Saudi Arabia
- Introduction 17:26 17:26
- Medical Devices Classification 14:14 14:14
- Medical Device Electronic System 05:42 05:42
- Guidance For Medical Devices Registration 10:02 10:02
- SFDA Submission Requirements 14:23 14:23
- Notified Body 06:52 06:52
- Classification 05:48 05:48
- Registration Forms 19:25 19:25
- Templates 11:52 11:52
- Bundling 16:39 16:39
- Bundling Diagrams 09:25 09:25
- MDMA Application Process 16:03 16:03
- Verification 05:46 05:46
- MDMA Certificate 20:20 20:20
- Clearance &PV 13:12 13:12
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.
User your certification to make a career change or to advance in your current career. Salaries are among the highest in the world.
Our students work
with the Best
Related Video CoursesView More
Become a valued member of Tutorials Point and enjoy unlimited access to our vast library of top-rated Video CoursesSubscribe now
Master prominent technologies at full length and become a valued certified professional.Explore Now