Saudi Arabia Medical Device Regulatory Process

This article provides an overview of the medical device regulatory system in the Kingdom of Saudi Arabia. The authors detail the regulatory history, framework and registration process, providing contact information as well as links to regulations and guidance documents. The article not only addresses the inception and progress of the Saudi Food and Drug Authority’s medical devices sector, but addresses its future plans and timelines. Topics covered:

  • Regulatory Authority
  • Legal Framework and Regulatory Controls
  • Local Representation
  • Strategy for Registration
  • Labelling
  • and more

About the Authors:
Michael A Siano is a Global Regulatory Specialist with Emergo, specialising in global regulatory strategy and EU, Middle East, and South East Asian regulatory affairs. He holds a Master’s in Microbiology from the University of Texas at Austin and a Bachelor degree in Molecular, Cellular & Developmental Biology from the University of California at Santa Cruz. Prior to entering the regulatory field, he worked in biotechnology and software development.

Emad Elmasry is the Middle East Managing Director with Emergo, based in Cairo, Egypt. He has worked in regulatory affairs since medical device regulations first came to the Middle East over a decade ago. Prior to Emergo Group, his work included hiring and managing distributors and sales teams as well as managing several start-ups across the Middle East. He holds a degree in Telecommunication Engineering from Helwan University, and advanced certificates in Sales & Marketing and Business Administration from the American University in Cairo.

M. Elizabeth Nowrouz is a Regulatory Associate with Emergo, specialising in Saudi and South East Asian medical device registrations. She holds a Bachelor degree in English from the University of Mary Washington, and studied Middle Eastern Studies at the American University in Cairo.

This article previously appeared in the Journal of Medical Device Regulation (JMDR), Volume 11 (3); August 2014.