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.

Countries to be covered include:
Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, Tunisia, UAE, Yemen

Please note we are also running a seminar on Pharmaceutical Regulatory Affairs in the Middle East 18-19 June 2018. Please visit www.management-forum.co.uk for further information.

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

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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Previous customers include...

  • ArjoHuntleigh AB
  • Asahi Intecc Co., Ltd.
  • Bayer Medical Care B.V.
  • Beckman Coulter International SA
  • Biomet UK Healthcare Ltd
  • Britannia Pharmaceuticals Ltd
  • Coloplast A/S
  • CooperVision Manufacturing Ltd
  • Ego Pharmaceuticals Pty Ltd
  • Ginsana SA
  • Hospira (ME & NA)
  • MEDRAD Europe BV
  • Medtronic Ireland
  • Merit Medical Nederland BV
  • Molnlycke Healthcare
  • Nobel Biocare Holding AG
  • Novartis Vaccines Diagnostics Services AG
  • Novo Nordisk Gulf Health Care
  • Olympus KeyMed Ltd
  • Olympus Surgical Technologies America
  • Omron Healthcare Europe BV
  • Omron Healthcare Middle East
  • Pfizer Gulf FZ LLC
  • PHIBO Middle East
  • Radiometer Medical ApS
  • Sinclair Pharmaceuticals
  • Smiths Medical International Ltd
  • Varian Medical Systems
  • Varian Medical Systems Int AG
  • William Cook Europe ApS

It was good. The flow was very nice.

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

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

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

All great

Simona Fiori, Regulatory Market Specialist, Orthofix Srl

Good structure

David Owolabi, Senior Regulatory Specialist, Steris Ltd

Great day, informative and good interaction – would recommend

Elaine Gibbons, Regulatory Affairs Specialist, Merit Medical EMEA

Very good presentations and binder

Anette Hulstrøm, Specialist Regulatory Affairs, William Cook Europe ApS

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

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