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Regulatory requirements of Medical Devices in MENA ... - DGRA

I Regulatory requirements of Medical Devices in MENA countries Wissenschaftliche Pr fungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen Fakult t der Rheinischen Friedrich-Wilhelms-Universit t Bonn Vorgelegt von Dr. Fatemeh Samadi aus dem Iran Bonn, Februar 2015 II Betreuer und 1. Referent: Dr. Ehrhard Anhalt 2. Referent: Dr. Birka Lehmann III Table of Contents LIST OF TABLES .. V LIST OF ANNEXES .. VI LIST OF ABBREVIATIONS .. VII EXECUTIVE SUMMARY .. 1 1. INTRODUCTION .. 2 DEFINITION OF MENA COUNTRIES .. 2 MENA HEALTHCARE MARKET .. 2 MENA Medical Devices MARKET .. 4 2 Medical Devices REGULATION .. 8 Medical Devices REGULATION HISTORY .. 8 INTERNATIONAL Medical Devices REGULATORS FORUM.

Middle East and the North African countries (MENA), to show their limits and their prospects. The Medical Devices market in this area presents unique challenges and opportunities to international manufacturers in the health care sector. Although the Medical Devices market in the MENA region is very diverse most of the individual

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