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Biography

Sara Hegazi is Quality & Regulatory professional in medical devices in Philips Healthcare, covering Middle East &Turkey (MENA region). She is a member of Mecomed, and she has experience in managing registration requirements in 20 countries in Middle East. She has directed Post-Market Surveillance/Vigilance and served as compliance officer. She has also had responsibility for quality assurance, audit management, healthcare compliance, and clinical functions.

Abstract

Middle East region is one of fastest growing medical devices market in the world, providing significant opportunities for medical devices development and marketing. At the same time, the Middle East region is one of the most vibrant areas in the world and presents a major challenge:Challenges facing the healthcare industry throughout the MENA region as populations grow and life expectancy increases. A key issue in the region remains the growing number of chronic conditions and diseases such as diabetes, obesity and heart disease. The medical infrastructure must also improve and expand; healthcare authorities in the MENA region are playing a vital role to develop &improve advanced regulatory guidelines to adapt to new challenges, as well leading educating and training local workforces, which can only be achieved by partnering with international companies. It is estimated the GCC healthcare market is to grow 11% per annum to $43 billion by 2015 and on to $60 billion by 2025. The UK healthcare system is highly regarded throughout the MENA region and opportunities are available across all aspects of the healthcare sector.The challenges are different for each country. Challenges are still remaining, which include understanding the local requirements, communicating effectively. With the authorities, managing the time to receive the approvals, and providing solutions for the unexpected problems.A successful regulatory strategy requires a strong understanding of the regulations, guidelines, and effective Communications with internal stakeholders and with the health.Authorities & take advantage of the opportunities to expand their products in this dynamic part of the world.