Medical Device Regulation Masterclass – MENA

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Enrolled: 0 students
Duration: 8 weeks
Lectures: 7
Level: Beginner

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Working hours

Monday 9:30 am - 6.00 pm
Tuesday 9:30 am - 6.00 pm
Wednesday 9:30 am - 6.00 pm
Thursday 9:30 am - 6.00 pm
Friday 9:30 am - 5.00 pm
Saturday Closed
Sunday Closed

This course has been designed to help individuals build up a solid and comprehensive framework in the
medical device’s regulatory affairs, and to provide a basic understanding of the medical devices including
IVDs., addressing market information, technical documents, and guidelines of the related authorities
in the MENA region.

1. Gain an extensive understanding of the important rules and regulations of medical devices and the related authorities in the MENA region.
2. Get an overview of the EU medical device regulations.
3. Understand the need for medical device regulations.
4. Gain comprehensive knowledge about the medical devices market in the MENA region.
5. Learn the steps and procedures of the MD registration in each country separately.
6. Understand the technical dossier requirement and required certificates and how to obtain them
(such as CE and ISO)
7. Get an overview of the importation procedures of the medical devices as per the competent
authority.
8. Understand the medical devices quality standards for the MENA region We are a leading provider of professional training for the medical and pharmaceutical industry.
Relying on our extensive training portfolio with expert instructors and recognized certifications.
If you want to understand the rules that govern the Regulation of medical devices in the middle
east Market place this course is perfect for you.

Medical Devices Introduction

File size: 2 mB

22-May

1
Introduction to Medical Device (IVDs)
240
2
Introduction to Medical Device (IVDs)
10 questions

29-May

1
EU Medical device regulations / (IVDs)( MDD and new MDR)
240
2
EU Medical device regulations / (IVDs)( MDD and new MDR)
10 questions

5-Jun

1
GCC Medical Device registration ( Part2) – UAE , Oman , Bahrain , Qatar, and Kuwait
2
GCC Medical Device registration ( Part2) – UAE , Oman , Bahrain , Qatar, and Kuwait

12-Jun

1
GCC Medical Device registration (part 1) – KSA 
2
GCC Medical Device registration (part 1) – KSA 

19-Jun

1
Egypt and Sudan Medical devices regulation
2
Egypt and Sudan Medical devices regulation

26-Jun

1
Levant Medical device regulations ( Syria , Jordan , Palestine, Lebanon, and Iraq)
2
Levant Medical device regulations ( Syria , Jordan , Palestine, Lebanon, and Iraq)

3-Jul

1
Materiovigilance in EU
2
Materiovigilance in EU & and QSR in ME