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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.

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

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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Details

Course overview

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

Who should attend

The event 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

Programme

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

Programme

Economic Overview

Saudi Arabia

GCC Prequalification GPP

GCC Medical Device Regulation

Kuwait

Bahrain

Oman

Yemen

UAE

Iran

Eygpt

Algeria

Morocco

Tunisia

Israel

Palestine

Syria

Jordan

Lebanon

Iraq

Sudan

Medical Device Network

Presenters

Ilona Putz (More...)

Ilona Putz is the founder and General Manager of PULONA Emerging Markets based in the UAE since 2008. Her company is dedicated to creating and developing tailor-made business concepts including regulatory consultancy for international manufacturers in the healthcare sector across the Middle East. Ilona has worked in the Pharmaceutical Industry since 1988 for companies like MSD, SmithKline Beecham, Karl Engelhard, HEXAL and Sandoz where she was the Regional Head, Middle East, for Sandoz International, Germany, responsible for all commercial and business development activities. She also consults for RegAff, Emergo and Dr. Regenold GmbH for the Middle East. Ilona spoke during the DIA Europe Meeting on “Clinical Trials in the Middle East” and at the Global Pharmaceutical Regulatory Affairs Summit 2021.

Heba Hashem (More...)

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.

Customise

Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 15-16 Jun 2022
  • 20-21 Sep 2022
  • 7-8 Dec 2022

Book now

You may also be interested in

Previous customers include...

  • Annette Callaghan Ltd
  • Bayer Medical Care B.V.
  • Beckman Coulter International SA
  • Coloplast A/S
  • CooperVision Manufacturing Ltd
  • DextReg
  • Fujirebio-Europe NV
  • Ginsana SA
  • Hospira, a Pfizer company
  • Institut Straumann AG
  • ISS AG, Integrated Scientific Services
  • Johnson & Johnson
  • MAQUET Middle East FZ-LLC
  • MEDRAD Europe BV
  • Merit Medical Nederland BV
  • Novartis Vaccines Diagnostics Services AG
  • Novo Nordisk Gulf Health Care
  • Olympus Keymed
  • Omron Healthcare Europe BV
  • Orthofix Srl
  • Radiometer Medical ApS
  • Septodont
  • Sinclair Pharma
  • Smiths Medical International Ltd
  • STERIS
  • Sybermedica Ltd
  • TUV RheinlandInternational GmbH
  • Varian Medical Systems Int AG
  • Vertex-Dental B.V.
  • WEINMANN Emergency Medical Technology GmbH + Co. KG

The course was very informative and the booklet I can take home is fantastic to look back on when a query arises. The speakers were very informative and kept the course interesting.

Michelle Lord, RA Officer, Sinclair Pharma, Jun 19

The speakers were really friendly and were able to answer questions from the listeners.

Jonas Friederich, Regulatory Affairs Manager , WEINMANN Emergency Medical Technology GmbH + Co. KG , Jun 19

I was hoping to get clarification on regulations in the MENA market and find out about any updates and I believed I have accomplished that. A very good course – organised very well, great venue and good speakers.

Agata Chmielewska, RA/QA Specialist, CooperVision, Jun 19

Very good course, covered just enough to have a good overview in the time given. The course was organised very well, a great venue, good speakers.

Agata Chmielewska, RA/QA Specialist, CooperVision, Jun 19

Very good course, covered just enough to have a good overview in amount time given.

Agata Chmielewska, RA/QA Specialist, CooperVision, Jun 19

Very good course, covered just enough to have a good overview in amount time given.

Agata Chmielewska, RA/QA Specialist, CooperVision, Jun 19

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, Jun 18

It was good. The flow was very nice.

Stephanie de Souza, Regulatory Officer, Vertex-Dental B.V. , Jun 18

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

Manuela Müller-Maissen, Senior Regulatory Affairs Specialist, Varian Medical Systems, May 17

All great

Simona Fiori, Regulatory Market Specialist, Orthofix Srl, May 17

Good structure

David Owolabi, Senior Regulatory Specialist, Steris Ltd, May 17

Very good presentations and binder

Anette Hulstrøm, Specialist Regulatory Affairs, William Cook Europe ApS, May 17