Saudi Arabia adopts interim device authorisation regulation
This article was originally published in RAJ Devices
Executive Summary
Saudi Arabia has adopted an interim marketing authorisation regulation under which, possibly as early as 2010, only medical devices that have been approved by the Saudi Arabia Food and Drug Administration will be allowed on the market1. Additionally, only medical devices that comply with the regulations in force in the European Union, the US, Canada, Japan or Australia – ie in the jurisdiction of a Global Harmonization Task Force founding member - will be eligible for marketing in the country2,3.