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.
Year
DOI
Venue
2015
10.3233/978-1-61499-538-8-23
Studies in Health Technology and Informatics
Keywords
Field
DocType
Medical Device,Registry,Surveillance system,Saudi Arabia
Medical education,Knowledge management,Optometry,Medicine
Conference
Volume
ISSN
Citations 
213
0926-9630
1
PageRank 
References 
Authors
0.64
0
4
Name
Order
Citations
PageRank
k alsurimi113.68
Mowafa S. Househ211631.32
e almohandis310.64
f alshagathrh410.64