Medical Device Regulations in the Middle East

This In-house course will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East.

Course Overview

This In-house course will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East. 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:
Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE, Yemen

What Team Would Benefit

This seminar will be of particular interest to: *Anyone involved in regulatory affairs for medical devices in the Middle East
  • Anyone new to the region
  • Anyone interested in an update of recent developments

Benefits

  • 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
  • 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

Sample Programme

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

Welcome and Introduction

The Medical Device Markets in the Middle East
  • 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 day