CHALLENGES FACING MEDICAL DEVICE REGULATIONS IN SAUDI ARABIA: A MIXED- METHOD APPROACH

Abstract

The Saudi Food and Drug Authority (SFDA) medical device regulatory system is well- established and comprehensive, however, had never been meticulously studied and assessed for effective implementation. This investigative study is the first to explore the SFDA medical device regulatory framework, assess how medical device regulations were implemented and identify regulatory challenges facing the (SFDA), medical device companies and healthcare facilities in Saudi Arabia. A mixed-research method was developed with data triangulation results from three sources, a literature review of journal articles, SFDA databases and regulation documents, followed by an online questionnaire that targeted biomedical engineers working in the medical device industry in Saudi Arabia, and six online email and video-call interviews with SFDA regulatory officials, professionals and experts in the field. As a result, a total of nine regulatory challenges facing medical device regulations in Saudi Arabia were identified, among them, eight were new insights to the existing literature, including challenges facing the SFDA medical device sector, healthcare facilitates in Saudi Arabia and the medical device national community. Finally, recommendations with solutions were provided to address the identified challenges.