Master Medical Devices Registration in Europe
Manage medical devices regulatory activities in the European market /Be the expert of EU market
Lectures -12
Resources -5
Duration -2.5 hours
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Course Description
Master medical devices registration in the most important and biggest market ever in the world, the European market, 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 regulatory affairs professional to achieve the company revenue from this interesting part of the world on one hand while on your other hand you are dealing with the second most powerful tool of the medical devices, as medical devices registration time frame is shorter than the pharmaceuticals, it 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 Europe.
Dear pharma industry future professionals, let us start our interesting journey towards medical device registration in Europe, we will travel together to Europe, 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 Europe, 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 the European market importation.
And finally, congratulations to you for mastering medical device registration in the European 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
Goals
What will you learn in this course:
Master medical devices registration in Europe
Manage medical devices regulatory activities in Europe
Place your medical devices in the market of Europe
Master the European market by medical devices
Prerequisites
What are the prerequisites for this course?
Just the PC and welling to stand out of the crowd
Curriculum
Check out the detailed breakdown of what’s inside the course
Master Medical Devices Registration in Europe
12 Lectures
- Introduction 08:00 08:00
- Definition 17:48 17:48
- EMA Regulatory Pathway 23:36 23:36
- Borderline products 07:47 07:47
- Stakeholders 16:20 16:20
- EMA MD Regulations 17:44 17:44
- CE Mark 07:39 07:39
- Free Sale Certificate 16:04 16:04
- New EMA regulations 14:48 14:48
- System/procedure packs 20:22 20:22
- Tracking/Tracing 11:21 11:21
- EUDAMED 09:05 09:05
Instructor Details
Zahra Hassan Sobhy
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