Introduction to Saudi Arabia's Medical Device Approval Process

Saudi Arabia is one of the world's top 20 global economies. It has close to 29 million people, and about 95% of its market is supplied by imports. Interested in entering this prime market for medical devices? This short video provides an overview of how Saudi Arabia regulates medical devices. Topics covered include the Saudi Food and Drug Authority (SFDA), leveraging your device approval from a reference market (Australia, Canada, Europe, Japan, and/or the USA), requirements for quality systems from your reference market, Local Authorized Representative in Saudi Arabia, Medical Device Market Application (MDMA), and more.

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Regulatory Chart about the process to approval in Saudi Arabia

Saudi Arabia Country Report
Free white paper provides an overview of the medical device regulatory system in the Kingdom of Saudi Arabia.