Interested in selling your medical device in Saudi Arabia? If so, there are a lot of things to know about Saudi Arabia's regulatory process before you get started. The Saudi Food and Drug Authority (SFDA) relies on reference market approval, but it is not a "rubber stamp" registration. SFDA's medical device review process is very rigorous and simple mistakes can delay your device approval.
In this article, we will cover important aspects of the SFDA regulatory process, including the regulatory history, framework, and registration process, with links to regulations and guidance documents. We will also answer your biggest questions about how to proceed with the SFDA submission process, including:
- Do we need in-country representation?
- How can product grouping simply our registration process?
- How do we select our device's reference country?
- How does the SFDA classify medical devices?
- What materials should we include in the registration dossier?
We will discuss all this and much more in this 10-page white paper.
About the Authors:
Michael A Siano is a Senior Global Regulatory Specialist with Emergo, with expertise in global regulatory strategy and EU, Middle East, and South East Asian regulatory affairs. He holds a master's degree in microbiology from the University of Texas at Austin and a bachelor's 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, 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.