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Master medical devices registration in kingdom of Bahrain

person icon Zahra Hassan Sobhy

4.2

Master medical devices registration in kingdom of Bahrain

manage medical devices regulatory activities in kingdom of Bahrain market/Be the expert of kingdom of Bahrain market

updated on icon Updated on Jun, 2025

language icon Language - English

person icon Zahra Hassan Sobhy

English [CC]

category icon Business,Industry,Medical Device Development

Lectures -14

Resources -25

Duration -3 hours

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4.2

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Course Description

Master medical devices registration in one of the most interesting parts of the GCC countries, a relatively small market, mainly driven by the market, full of opportunities, let's grasp the opportunity and place our medical devices there in the market of the Kingdom of Bahrain.

In this course, I will take you on such an interesting journey with the Ministry of Health of Bahrain, to master our medical devices registration there, let's practice regulatory affairs, registration, renewal, variations with all its types, classification, case by case, using actual examples from practice. As I always keep my theme in the pharma academy that "It comes to you from practice"

The market of the kingdom of Bahrain is quite small compared to other GCC markets, which are saturated with most of the kinds of products, such as the leader of the region "KSA" and the gulf region business hup "UAE", which means there is a huge opportunity waiting for us there, to master the market and have quite a big market share, especially with medical devices, due to the continuous innovations of the medical devices, and do not forget about the tenders, they are basic market players in all GCC countries markets.

So from a business point of view, considering the registration timeframe between 6 to 9 months maximum, 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 Bahrain market.

In this course, we will cover all topics related to medical devices in Bahrain, which will empower you to master the market. 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 application, and interact with the actual system for the submission

And we will end our journey by landing the department of customs clearance, tracking /tracing system, barcoding, 2DMatrix for all the shipments planned for the Kingdom of Bahrain market importation.

The system, which was first implemented by KS, the leader of the region, and then Oman, UAE, Bahrain, has been followed so far, and the others are coming soon.

And finally, congratulations to you for mastering medical device registration in the Bahrain market, and see you soon in the pharma industry, my dear colleagues.

Goals

  • Master medical devices registration in the Kingdom of Bahrain

  • Manage medical devices regulatory activities in the Kingdom of Bahrain

  • Place your medical devices in the market of the Kingdom of Bahrain

  • Be the expert in the Kingdom of Bahrain market

Prerequisites

  • Just the PC and willing to stand out from the crowd

Master medical devices registration in kingdom of Bahrain

Curriculum

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

Master medical devices registration in kingdom of Bahrain

14 Lectures
  • play icon Introduction 14:43 14:43
  • play icon Overview 12:51 12:51
  • play icon Classification 10:50 10:50
  • play icon Classification Circulars 11:48 11:48
  • play icon The authorised Representative 10:42 10:42
  • play icon The Workflow 11:08 11:08
  • play icon The Bundling 13:34 13:34
  • play icon The application form 19:35 19:35
  • play icon Dossier building 09:48 09:48
  • play icon Quality Assurance 10:51 10:51
  • play icon Verification/Renewal/variation 20:24 20:24
  • play icon Labelling 09:08 09:08
  • play icon Importation 17:39 17:39
  • play icon Pharmacovigilance 13:25 13:25

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 through postgraduate 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 at Bordeaux University France
Even though postgraduate studies for sure will certainly add to the profile, the practice is something else, At the beginning 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 pocket. This simply happens when you follow your passion.

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