Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory requirements of medical devices in MENA countries ***

Dr. Fatemeh Samadi (Abschlußjahr: 2015)

Summary
Language: English
The objective of this Master Thesis is to define the regulatory environment for Medical Devices in the 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 economies have shown sustainable growth. This growth is driven by several factors including a growing population of 400 million people, the price of oil and energy, an increase of the Gross Domestic Product (GDP) and the income per capita, an improved literacy rate, a larger middle class and also a higher disease rate.
In this market, Medical Devices are one of the most important health intervention tools available for the prevention, diagnosis and treatment of diseases and for patient rehabilitation. The growth of demand for sophisticated pharmaceutical and medical products in the MENA region seen in recent years is only likely to continue.
Despite of the overall positive economic development in most of the MENA countries the regulatory environment can be challenging. Publicly accessible written legislations are limited in these countries, sometimes are only available in the local language (mostly Arabic) and leave room for interpretation. Also important to mention in this context are the barriers for the continuing evolution of the regulatory environment in some of these emerging countries due to their political instability, non-transparency and corruption.
Against this background the efforts of the Global Harmonization Task Force (GHTF) to harmonize the Medical Devices regulation, offer a valuable contribution to ease the regulatory interconnection and intercommunication between the individual countries and the international economic operators of the Medical Devices industry.
The follower of GHTF - the International Medical Devices Regulators Forum (IMDRF) - builds on the strong foundational work of the GHTF and accelerates the international Medical Devices regulatory harmonization and convergence.  The impact of the EU on the harmonization in these countries is rising.
Pages: 61
Annexes: XVI, Pages: 74