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Medical Device Regulations in the MENA Region

4-week online course | 2 hours per week

Next intake begins 1 October 2019

Online Academy

By 2020 the MENA Medical devices region is expected to be worth $9.8 Billion. One of the key boundaries that companies have in the region is that there are key regulatory challenges for each country.

Having a solid regulatory strategy in the region will require an in depth knowledge of the regulations and can open up a growing market. The region consists of markets with different regulatory systems and requirements and with this 4-week online course you will get a thorough understanding on the difficulties that companies usually face and how to avoid slow or failed submissions.

Ilona Putz has worked in the Pharmaceutical Industry since 1988 for companies like MSD, SmithKline Beecham, Karl Engelhard and HEXAL where she has held the position of Regulatory Affairs Regional Manager, responsible for regulatory affairs and later on in commercial operations for countries in the Middle East and Africa. Between 2005 and August 2008 she was Regional Head, Middle East, for Sandoz International, Germany, responsible for all commercial and business development activities.

Ilona consults for Regulatory Affairs for the Middle East which is the only Global Specialist Regulatory Affairs company with a broad geographical coverage, and for Emergo Group, which is a global consultancy company for Medical Devices.

  • Guidance on dossier requirements and structure to avoid rejections and gain faster approval of devices
  • Learn about future regulatory developments in the region
  • Understand regional and national systems of standards for medical devices
  • Learn about the medical device trends in the MENA Region
  • Compare key regulatory differences between regulatory submissions in major countries.
  • Gain an overview on the markets
  • Be clearer on cultural differences

This course would be useful for people within regulatory affairs departments who have local representations in these markets and want to know more about the region. It will provide them with an overview and would allow them to monitor local representatives more thoroughly.

This course would also be good for local representatives wanting to learn more about other countries registrations.

MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.


Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

Watch the Online Academy Video

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