Medical Device Regulations in the Middle East and North Africa

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

19-20 Jun 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. The programme will cover the regulatory requirements and developments in the individual countries. The course will include interactive discussion sessions to allow you to exchange experiences with other delegates.

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

Book both

This meeting runs back-to-back with our Pharmaceutical Regulatory Affairs in the Middle East 17-18 June 2019, and there is a further £200/€280 discount when booked together.

To register on both events click HERE

To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail

*Please note* we are also running a seminar on Pharmaceutical Regulatory Affairs in the Middle East *17-18 June 2019*. If you would like to attend both at a specially discounted rate, please call our customer services team.

Who should attend

This seminar will be of particular interest to:

  • Anyone involved in regulatory affairs for medical devices in the Middle East and North Africa
  • Anyone new to the region
  • Anyone interested in an update of recent developments

Benefits of attending

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


This course will cover Regulatory Activities in:
Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Israel, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE, Yemen & Jordan

Welcome and Introduction

The Medical Device Markets in the Middle East and North Africa
  • 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
  • Country presentations
Medical Devices and their Classification
  • What is a medical device
  • Different classes of products
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 will take place throughout the two days


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.

Heba Hashem

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.

Book now

19-20 Jun 2019
19-20 Jun 2019 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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  • DextReg
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  • Novartis Vaccines Diagnostics Services AG
  • Olympus Keymed
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  • Omron Healthcare Europe BV
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  • Smith & Nephew US Limited
  • Smiths Medical International Ltd
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  • Varian Medical Systems
  • Varian Medical Systems Int AG
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Generally the content flowed well, but there was a couple occasions where the slides were changed a little too quickly...

Kelly Jeffs, Regulatory Affairs Specialist, CooperVision Manufacturing Ltd

It was good. The flow was very nice.

Stephanie de Souza, Regulatory Officer, Vertex-Dental B.V.

All great

Simona Fiori, Regulatory Market Specialist, Orthofix Srl

Very good, covered many countries in a short time. Will recommend the course.

Manuela Müller-Maissen, Senior Regulatory Affairs Specialist, Varian Medical Systems

Very good presentations and binder

Anette Hulstrøm, Specialist Regulatory Affairs, William Cook Europe ApS

Great day, informative and good interaction – would recommend

Elaine Gibbons, Regulatory Affairs Specialist, Merit Medical EMEA

Good structure

David Owolabi, Senior Regulatory Specialist, Steris Ltd