Master Medical Devices Registration in the UK

person icon Zahra Hassan Sobhy

Master Medical Devices Registration in the UK

Manage medical devices regulatory activities in the UK

updated on icon Updated on Sep, 2023

language icon Language - English

person icon Zahra Hassan Sobhy

architecture icon Business,Industry,Pharmacy


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Course Description

Master medical devices registration in the most important and biggest market ever in the world, the market of the UK, 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 to achieve the company revenue from this interesting part of the world on 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, its 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 UK.

Dear pharma industry future professionals, let us start our interesting journey towards medical device registration in UK, we will travel together to the UK, meet the health authority there "MHRA", and explore its requirements for registration, renewal, and variations, let us place our products there.

In this course, we will cover all topics related to medical devices in the UK, 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, of the medical , and interact with the actual MHRA gateway for the 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 UK market importation.

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

Who this course is for:

  • All levels of the pharma industry, starting from the fresh graduates till the highly professionals


What will you learn in this course:

  • Master medical devices registration in the UK

  • Manage medical devices regulatory activities in the UK

  • Place your medical devices in the UK market

  • Master the UK market by medical devices


What are the prerequisites for this course?

  • Just the PC and welling to stand out of the crowd

Master Medical Devices Registration in the UK


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

Master Medical Devices Registration in the UK
13 Lectures
  • play icon Introduction 13:14 13:14
  • play icon MHRA Guidelines 10:25 10:25
  • play icon MHRA Foundation 12:29 12:29
  • play icon MHRA Milestones 12:18 12:18
  • play icon Registration with MHRA 14:48 14:48
  • play icon QMS Compliance 10:53 10:53
  • play icon Class IMD insights 21:33 21:33
  • play icon Variations with MHRA 13:34 13:34
  • play icon Northern Ireland 10:49 10:49
  • play icon MHRA Brexit 13:52 13:52
  • play icon Brexit Millstones 31:56 31:56
  • play icon North Ireland Brexit 15:06 15:06
  • play icon Summary 08:02 08:02

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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