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THE PHARMA REVIEW (JULY AUGUST 2019)

Clinical Evaluation and Post Marketing Surveillance of Medical Devices in Saudi Arabia

Sanhita Singha Roy1 & Dr. Balamuralidhara V.2

Introduction: With some of the richest economies in the world, the Gulf Cooperation Council (GCC) is undergoing rapid growth not only in its population but also in health care expenditure. With respect to the medical device regulatory environment in the GCC, each member state has its own system in differing stages of maturity. The member state considered for this study is Saudi Arabia, which is also one of the emerging markets GCC. The health care system in Saudi Arabia is the largest and most technologically advanced in the GCC. In Saudi Arabia, regulatory authorization is required for all medical devices, regardless of device class. On the other hand clinical evaluation of medical devices is essential for obtaining a market authorization followed by a proper post market surveillance system after the device enters the market. Similar to its US counterpart, the SFDA has instituted post-market surveillance requirements to ensure medical device safety and quality after introduction to the market. The aim of this study is to focus on the requirements for clinical evaluation and post marketing surveillance of medical devices in Saudi Arabia.

 

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