Be the expert of placing medical devices in the highly dynamic market of the United Arab Emirates, the business hub
What you’ll learn
- By the end of this course you will master medical devices registration in the United Arab Emirates
- By the end of this course you will master all regulatory activities of medical devices in the United Arab Emirates
- By the end of this course you will place medical devices in the business hub of the Middle East
- By the end of this course you will place medical devices in the highly dynamic market of Dubai
This course includes:
- 4 hours on-demand video
- 19 downloadable resources
- Access on mobile and TV
- Full lifetime access
- Closed captions
- Certificate of completion
Course content
17 sections • 17 lectures • 3h 56m total length
Description
Master Medical Device Registration in the UAE—Your Gateway to the Middle East Market!
Take a journey with us to the dynamic business hub of the Middle East—Dubai, United Arab Emirates—and learn how to successfully place your medical devices in one of the region’s most competitive and high-potential markets.
In this comprehensive, step-by-step course, you’ll gain practical expertise in every stage of medical device registration, from classification and manufacturing compliance to dossier preparation, submission, and renewals. With real-world examples, templates, and hands-on guidance, you’ll walk away ready to navigate UAE regulatory processes confidently and efficiently.
What You Will Learn
- Introduction to UAE medical device regulations
- Device classification: normal, in-vitro, and active medical devices
- Regulatory requirements, clarification rules, and documentation
- Manufacturer compliance and ISO 13485 standards
- CE certificate approvals and their relevance
- Step-by-step guidance through Medical Device Registration Guidelines (2011–current)
- Building your submission dossier: forms, templates, and checklists
- Managing high-risk “Pharmaceutical-Like Dosage Forms”
- Renewal procedures and updated MOH circulars
- Practical workflow: from registration to market placement
Why You Should Enroll
- Gain hands-on knowledge of UAE medical device registration from start to finish
- Learn practical tools and checklists to simplify complex regulatory processes
- Understand how to manage high-risk devices and ensure compliance
- Save time and avoid common pitfalls with step-by-step guidance and real examples
- Position yourself as a regulatory expert in a fast-growing, high-value market
Takeaway Message
By the end of this course, you’ll be fully equipped to classify, register, and maintain medical devices in the UAE, navigate all regulatory steps, and confidently manage renewals and compliance updates.
Join this journey, take control of your medical device registrations, and unlock the full potential of the UAE market—let’s take off!
Who this course is for:
- All Pharma industry professionals, regulatory affairs professionals, and those who decide to start their career in the pharma industry
Instructor
Dr. Zahra Hassan
- 4.1 Instructor Rating
- 465 Reviews
- 1,286 Students
- 32 Courses
A highly dedicated and detail-oriented regional regulatory affairs manager for the MENA Region, Europe, USA, LATAM, Brazil, and Asia, I bring over 16 years of comprehensive experience in the pharmaceutical industry. As a licensed pharmacist with global exposure, my career spans pharmaceuticals, general sale products, regulatory affairs, pharmacovigilance, compliance, and life-cycle management across multinational organizations.
My professional journey covers the full regulatory spectrum—including product registration, renewals, variations, contract management, aftermarket regulatory activities (PV), and cross-functional leadership. I have consistently supported organizations with strategic regulatory planning, multi-project management, and effective communication with Health Authorities, regulatory agencies, and global partners.
I possess strong experience in clinical and regulatory operations, as well as their integration with R&D, production, quality, market access, and product launch activities. I regularly deliver presentations, business proposals, training sessions, and regulatory strategies to internal teams and external partners.
My background also includes:
Technical expertise in medical device regulations, CTD/eCTD submissions, CMC, Quality Management Systems, and Post-Market Surveillance
Leading teams, mentoring juniors, and supporting onboarding processes
Implementing global and local SOPs aligned with META region requirements
Conducting PV training for field safety teams and ensuring proper safety reporting
Strong understanding of pharmaco-economics, risk assessment, complaints handling, pricing issues, and customs clearance challenges
Experience in QA, ISO 9001, ISO 13485, GMP, audits, CAPA, RPP/QPPV, and internal regulatory systems
Academically, I hold:
MSc in Pharmacovigilance
MSc in Pharmaco-Economics
RAP/RAC credentials
MOH License
I value continuous learning, constructive feedback, and collaborative problem-solving. My mission is to transform real-world regulatory and PV expertise into practical, accessible learning that empowers students to excel in their careers across the pharmaceutical and healthcare industries.