Master Medical Device Registration in the UAE

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About Course

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.

 

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!

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What Will You 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

Course Content

Module 1: Introduction
In this practical and career-focused course, you will learn step-by-step how to successfully register medical devices in the UAE. The course is designed to provide regulatory professionals, pharmacists, medical device specialists, and industry newcomers with the knowledge needed to navigate the UAE regulatory system with confidence.

  • Introduction
    13:59

Module 2: Medical Devices Classification
This section is the actual start towards the very beginning step of medical devices which is the classification we will explore together the classification rules set by the MOH of UAE

Module 3: Classification Rules and Documents
In this section we will match the previous section medical devices classification guidance set by MOH of the UAE with the 3 major classes of all types of medical devices

Module 4: The Manufacturer
In this section, we will start the actual registration process by registering the manufacturing site, which is the first step towards any product registration with any health authority

Module 5: Quality
In this section, you will be introduced to the second step in our registration ladder, which is the Quality of such a manufacturing site, ensuring its quality, documents, and the notified body

Module 6: Marketing Authorization
In this section we will explore together the EU reference certification of market, which document issued by which health authority in COO of which medical device class proof marketing

Module 7: MD Registration Guidelines
In this section we will be introduced to the actual medical issued by the MOH of the UAE in 2011, AW requirements and its exemption cases for the tenders, LOA, Local agent, LSR, QPPV

Module 8: Site Dossier
In this section we will build up together the registration dossier for such medical devices starting with the site registration discovering its options, will explore SMF, and establishment license

Module 9: Registration Checklist
In this section we will go through the checklist of the registration of medical devices one by one in detail

Module 10: Summary of Registration
In this section we will sum up the checklist highlighting the special situations that usual faced in practice and how to overcome them.

Module 11: The Renewal
In this section we will explore together the renewal process, document, and the flow chart, in addition to the time frame of validity and the suitable time to submit for the renewal

Module 12: The Forms
In this section we will see and prepare the actual forms of submission starting by the site registration form, medical device registration form, and we will explain and fulfil each requirement

Module 13: Renewal & Closing
In this bonus lecture we will close the registration process of the medical devices with the MOH-UAE, with the renewal and its forms, in addition to the product importation and brand synchronization

Module 14: Importation Updates Part 1
Importation Updates

Module 15: Importation Updates Part 2
Importation Updates Part 2

Module 16: MOHAP MDR PART 1
MOHAP MDR

Module 17: MOHAP MDR PART 2
From the European MDR to the MOHAP MDR, Implementation and Milestone, with due dates

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