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.

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 info@management-forum.co.uk

*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

Programme

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

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

You may also be interested in

Previous customers include...

  • ArjoHuntleigh AB
  • Beckman Coulter International SA
  • Britannia Pharmaceuticals Ltd
  • Coloplast A/S
  • CooperVision Manufacturing Ltd
  • Fujirebio-Europe NV
  • Ginsana SA
  • IBA
  • ISS AG, Integrated Scientific Services
  • MAQUET Middle East FZ-LLC
  • Medtronic Ireland
  • Merit Medical Nederland BV
  • Nobel Biocare Holding AG
  • Nobel Biocare Services AG
  • Olympus Keymed
  • Olympus KeyMed Ltd
  • Omron Healthcare Europe BV
  • Orthofix Srl
  • Paul Hartman Middle East FZE
  • Pfizer Gulf FZ LLC
  • PHIBO Middle East
  • Saudi Food and Drug Authority
  • Smith & Nephew US Limited
  • Smiths Medical International Ltd
  • Sorin Group Italia
  • STERIS
  • Sybermedica Ltd
  • Varian Medical Systems
  • Varian Medical Systems Int AG
  • William Cook Europe ApS

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.

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

I found the day engaging and helpful. The willingness from the speakers for us to learn was evident, and I appreciated that they asked from the beginning what our expectations were for the day, and aimed to meet these.

Elaine Gibbons, Regulatory Affairs Specialist, Merit Medical EMEA

Good structure

David Owolabi, Senior Regulatory Specialist, Steris Ltd

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