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Medical Device Regulations in the Middle East and North Africa Training Course: Getting to Grips with a Fast Growing Market

DUBLIN, May 22, 2023 /PRNewswire/ -- The "Medical Device Regulations in the Middle East and North Africa Training Course" conference has been added to's offering.


The size of the medical device market in the Middle East has expanded over recent years and this trend is forecast to continue.

The growth is due in part to innovations in technology as the majority of Middle Eastern countries are early adopters of technological advancement, which provides opportunities for medical device companies. The regulatory environment in the region is also developing and this annual seminar will provide an essential overview of the key requirements for product approvals for medical devices in the Middle East and North Africa.

The programme will focus on the regulatory requirements and developments in individual countries and include interactive discussion sessions to allow you to exchange experiences with our expert faculty and other delegates.

Benefits of attending:

  • Gain a valuable introduction to the medical device markets: countries, numbers, economical facts and trends, regulatory environment
  • Familiarise yourself with medical device regulations in the countries of the Middle East and North Africa
  • Understand medical devices and their classification
  • Clarify procedures for company and product registration
  • Discuss recent developments in the region
  • Meet, network and share experiences with other industry colleagues

Key Topics Covered:

The medical device markets in the Middle East and North Africa (MENA)

  • Markets and Culture
  • Healthcare
  • Business culture
  • Economic overview
  • Regulatory environment and characteristics
  • General regulatory requirements
  • Company and product registration
  • Key documents needed
  • Basic structure of a dossier
  • Regulatory summary

Medical Devices and their classification

  • What is a medical device
  • Different classes of products

Individual Country Presentations:

  • Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

Recent Developments in the Region

  • Harmonisation activities
  • Countries with new regulatory requirements for medical devices
  • Countries in the process of establishing regulatory guidance for obtaining marketing authorisations

Discussion sessions will take place throughout the two days


Heba Hashem
Middle East and Africa Associate Director

Heba has been working with Regulatory Affairs in the Middle East for more than 25 years. She has a Pharmaceutical and Business background being a graduate of the Faculty of Pharmacy (Cairo University), RAC certified in addition to an MBA at Maastricht School of Business. For the past 20 years Heba held the position of Middle East & Africa Regulatory and Quality Head at different Pharmaceutical and Medical Device companies; Gambro, Bayer and Novo Nordisk.

Heba is now the Middle East and Africa Associate Director at PPD where she is providing regulatory consulting services and training to Health Care companies.

Ilona Putz

Ilona Putz founded PULONA Emerging Markets based in the UAE which is dedicated to creating and developing tailor-made business concepts for clients in the healthcare sector across the Middle East.

She 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.

She consults also for RegAff 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. She spoke also for DIA (Drug Information Association) Switzerland on "Clinical Trials in the Middle East", DIA Europe Meeting, Geneva 2011.

For more information about this conference visit

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SOURCE Research and Markets