Getting Digital

Master Medical Device Registration In Saudi Arabia

Develop essential medical & clinical skills with expert instruction and practical examples.

Online Course
Self-paced learning
Flexible Schedule
Learn at your pace
Expert Instructor
Industry professional
Certificate
Upon completion
What You'll Learn
Master the fundamentals of medical & clinical
Apply best practices and industry standards
Build practical projects to demonstrate your skills
Understand advanced concepts and techniques

Skills you'll gain:

Professional SkillsBest PracticesIndustry Standards
Prerequisites & Target Audience

Skill Level

IntermediateSome prior knowledge recommended

Requirements

Basic understanding of medical & clinical
Enthusiasm to learn
Access to necessary software/tools
Commitment to practice

Who This Course Is For

Professionals working in medical & clinical
Students and career changers
Freelancers and consultants
Anyone looking to improve their skills
Course Information

About This Course

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. What will you Learn. IntroductionMedical devices classificationMedical devices electronic systemGuidance on medical devices registrationSFDA submission requirements Notified body Classification Registration Forms Templates Bundling Bundling Diagrams MDMA Application process Verification MDMA certificationClerance and PVThis 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, 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, with lots of innovations and 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 in 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, and 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.

Provider
Udemy
Estimated Duration
10-20 hours
Language
English
Category
Health & Wellness

Topics Covered

Medical & Clinical

Course Details

Format
Online, Self-Paced
Access
Lifetime
Certificate
Upon Completion
Support
Q&A Forum
Course Details
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This course includes:

Lifetime access to course content
Access on mobile and desktop
Certificate of completion
Downloadable resources

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