Medical Device Regulations in the MENA region
Ilona Putz founded PULONA Emerging Markets in 2008, based in the UAE. Her company is dedicated to creating and developing tailor-made business concepts and regulatory services for clients in the healthcare sector across the Middle East and North Africa. She holds an MBA Degree from George Washington University and attended a Finance programme at Harvard Business School.
Ilona has worked in the Pharmaceutical Industry since 1988 for companies like MSD, SmithKline Beecham, Karl Engelhard, and HEXAL where she has held the position of Regulatory Affairs Regional Manager, responsible for regulatory affairs and later on in commercial operations for countries in the Middle East and Africa. Between 2005 and August 2008 she was Regional Head, Middle East, for Sandoz International, Germany, responsible for all commercial, business development, and regulatory activities.
Ilona consults also for RegAff for the Middle East which is the only Global Specialist Regulatory Affairs company with broad geographical coverage, and for Emergo Group, which is a global consultancy company for Medical Devices. She is a Speaker for Management Forum UK on “Pharmaceutical Regulatory Affairs in the Middle East” since 2006, on “Global Manufacturing Site Transfer” since 2009 and on “Medical Device Regulations in the Middle East” since 2012. She spoke also for DIA (Drug Information Association) Switzerland on “Clinical Trials in the Middle East”
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 such as Algeria, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE, and Yemen.
- Gain an introduction to the medical device markets: countries, numbers, economic facts, and trends, the regulatory environment
- Understand medical device regulations in the MENA region
- Get an overview of registration requirements, timelines, fees
- Clarify procedures for company and product registration
Medical Device regulations is an evolving era in the MENA region. Most of the MENA governments have published regulatory guidance as registration for some devices is required for importation.
Overview of the key areas of registration requirements for product and company approvals for medical devices in the Middle East and North Africa.
Course Level - Basic/Intermediate
Who Should Attend
- Anyone involved in regulatory affairs for medical devices in the MENA region
- Anyone new to the region
- Anyone interested in an update of recent developments
Why Should Attend
To understand the registration requirements for medical devices in the key markets in the MENA region to be able to efficiently plan submission strategies for the region.