Presented by
Management Forum

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

8-9 Dec 2021 + 3 more dates

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  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

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

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The Medical Device Regulations in the Middle East and North Africa course will cover:

Economic Overview

Saudi Arabia

GCC Prequalification GPP

Kuwait

Bahrain

Oman

Yemen

UAE

Iran

Eygpt

Algeria

Morocco

Tunisia

Israel

Palestine

Syria

Jordan

Lebanon

Iraq

Sudan

Medical Device Network

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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.

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Ilona Putz

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.

More details

Book Medical Device Regulations in the Middle East and North Africa Live online/Classroom training

8-9 Dec 2021

Live online

09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
04:00-11:30 New York (UTC-05)
Course code 11941

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 03 Nov

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15-16 Jun 2022

Live online

08:30-17:00 UK (London) (UTC+01)
09:30-18:00 Paris (UTC+02)
03:30-12:00 New York (UTC-04)
Course code 11675

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 11 May

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20-21 Sep 2022

Classroom
London venue TBC

08:30-17:00 UK (London)
Course code 11953

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 16 Aug

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

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7-8 Dec 2022

Live online

08:30-17:00 UK (London) (UTC+00)
09:30-18:00 Paris (UTC+01)
03:30-12:00 New York (UTC-05)
Course code 11952

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 02 Nov

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Reviews of IPI's Medical Device Regulations in the Middle East and North Africa training course


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

Jun 19 2019

Agata Chmielewska
RA/QA Specialist, CooperVision

Jun 19 2019

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 2019

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 2019

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 2019

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 2019

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

Agata Chmielewska
RA/QA Specialist, CooperVision

Jun 20 2018

It was good. The flow was very nice.

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

Jun 20 2018

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

May 22 2017

Very good presentations and binder

Anette Hulstrøm
Specialist Regulatory Affairs, William Cook Europe ApS

May 22 2017

Good structure

David Owolabi
Senior Regulatory Specialist, Steris Ltd

May 22 2017

All great

Simona Fiori
Regulatory Market Specialist, Orthofix Srl

May 22 2017

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

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

UK

  • Annette Callaghan Ltd
  • ArjoHuntleigh AB
  • Biomet UK Healthcare Ltd
  • Britannia Pharmaceuticals Ltd
  • BSN medical GmbH
  • CooperVision
  • CooperVision Manufacturing Ltd
  • Hospira, a Pfizer company
  • Molnlycke Healthcare
  • Olympus Keymed
  • Olympus KeyMed Ltd
  • Sinclair Pharma
  • Sinclair Pharmaceuticals
  • Steris
  • Steris Ltd
  • Stryker/HeartSine
  • Sybermedica Ltd
  • Thermo Fisher Scientific

Switzerland

  • Beckman Coulter International SA
  • Biotronik AG
  • Ginsana SA
  • Institut Straumann AG
  • ISS AG, Integrated Scientific Services
  • Nobel Biocare Holding AG
  • Nobel Biocare Services AG
  • Novartis Vaccines Diagnostics Services AG
  • Varian Medical Systems
  • Varian Medical Systems International AG
  • Zimmer GmbH

United Arab Emirates

  • Asahi Intecc Co., Ltd.
  • Hospira (ME & NA)
  • Johnson & Johnson
  • MAQUET Middle East FZ-LLC
  • Omron Healthcare Middle East
  • Paul Hartman Middle East FZE
  • Pfizer Gulf FZ LLC
  • PHIBO Middle East
  • Smith & Nephew US Limited
  • Smiths Medical International Ltd
  • Thermo Fisher Scientific Middle East

Netherlands

  • Bayer Medical Care B.V.
  • Bayer Medical Care BV
  • Fresenius HemoCare Netherlands BV
  • MEDRAD Europe BV
  • Merit Medical EMEA
  • Merit Medical Nederland BV
  • Omron Healthcare Europe BV
  • Vertex-Dental B.V
  • Vertex-Dental B.V.

Denmark

  • Coloplast A/S
  • Cook Medical
  • Radiometer Medical ApS
  • William Cook Europe ApS

Saudi Arabia

  • Novo Nordisk Gulf Health Care
  • Saudi Food and Drug Authority
  • TUV RheinlandInternational GmbH
  • Varian Medical Systems Int AG

France

  • DextReg
  • Horus Pharma
  • Septodont

Italy

  • Orthofix
  • Orthofix Srl
  • Sorin Group Italia S.r.l.

Australia

  • Cochlear Limited
  • Ego Pharmaceuticals Pty Ltd

Belgium

  • Fujirebio-Europe NV
  • IBA

Germany

  • WEINMANN Emergency Medical Technology GmbH + Co. KG

Ireland

  • Medtronic Ireland

Jordan

  • Fakhoury Medical Supplies Est - F.M.S.

Poland

  • LiNA Medical Polska Sp. z o.o.

United States of America

  • Olympus Surgical Technologies America

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy