@inproceedings{474ac659c27a4a4abc956d6be01aaf1b,
title = "Establishing a national medical device registry in Saudi Arabia: Lessons learned and future work",
abstract = "Medical device evaluation presents several unique challenges due to the great diversity and complexity of medical devices and their rapid technological evolution. There has been a variety of work conducted on the development of disease based registries and health surveillance systems in Saudi Arabia. However, the progress of medical device registry systems and post-market medical device surveillance systems remains in its infancy in Saudi Arabia and within the region. In 2007, a royal decree assigned the responsibility for regulating medical devices to the Saudi Food and Drug Authority (SFDA). Soon afterwards, the SFDA established the Medical Devices National Registry (MDNR) to house medical device information relating to manufacturers, agents, suppliers and end-users. The aim of this paper is to provide an overview on the Medical Device National Registry (MDNR) in Saudi Arabia and describe the current experience and future work of establishing a comprehensive medical device registry and post-market surveillance system in Saudi Arabia.",
keywords = "Medical Device, Registry, Saudi Arabia, Surveillance system",
author = "Khaled Al-Surimi and Mowafa Househ and Essam Almohandis and Fahd Alshagathrh",
note = "Publisher Copyright: {\textcopyright} 2015 The authors and IOS Press. All rights reserved.; 13th International Conference on Informatics, Management, and Technology in Healthcare, ICIMTH 2015 ; Conference date: 09-07-2015 Through 11-07-2015",
year = "2015",
doi = "10.3233/978-1-61499-538-8-23",
language = "English",
series = "Studies in Health Technology and Informatics",
publisher = "IOS Press",
pages = "23--26",
editor = "John Mantas and Househ, \{Mowafa S.\} and Arie Hasman",
booktitle = "Enabling Health Informatics Applications",
address = "United States",
}