Development of Protocol for Inspecting Imported Medical Devices in the Kingdom of Saudi Arabia

Abstract

The Kingdom of Saudi Arabia's healthcare sector has experienced remarkable growth in recent years, with a significant increase in the importation of medical devices from global manufacturers. The expanding medical device market requires strong inspection procedures to safeguard patient welfare and device effectiveness and fulfill international and national requirements. As the lead regulator of medical devices in Saudi Arabia, the Saudi Food and Drug Authority (SFDA) faces the essential task of creating detailed inspection procedures that maintain rigorous quality assurance and facilitate smooth market entry. The inspection protocols need to manage devices with multiple complexity levels that enter Saudi Arabia since they range from simple disposables to complex diagnostic tools and embedded medical devices that require separate examination rules and dangerous treatments. Standardized inspection methods should integrate global best practices, Saudi Arabian healthcare needs, local regulations, and capabilities for inspecting modern medical devices.