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.
authors.affiliation: College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Science, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia.
authors.forename: Khaled
authors.initials: K
authors.lastname: Al-Surimi
authors.affiliation: College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Science, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia.
authors.forename: Mowafa
authors.initials: M
authors.lastname: Househ
authors.affiliation: Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
authors.forename: Essam
authors.initials: E
authors.lastname: Almohandis
authors.affiliation: Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
authors.forename: Fahd
authors.initials: F
authors.lastname: Alshagathrh
mesh_terms: D033181:Information Dissemination; D062307:Medical Device Legislation / Q000458:organization & administration*; D010865:Pilot Projects; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012042:Registries; D012529:Saudi Arabia