Introduction

In accordance with the royal decree No. (M/6) issued on 25/01/1428H (13 February 2007) which assigned the responsibility of regulating medical-devices, in vitro diagnostic devices, prescription eye glasses, contact lenses and their solutions to the Saudi Food and Drug Authority (SFDA). And the council of ministers decree No. 181 on 03/06/1428H (18 June 2007) which gives the SFDA full authority to issue guidance that include rules and procedures of registering medical-devices establishments and their products. The Saudi Food & Drug Authority (SFDA) is responsible for protecting patients and the public from deficient medical products.

Saudi Food and Drug Authority (SFDA) represented by Medical Device Sector will be fully operational at the nine selected Ports Of Entry (MDPOE) to work next to Saudi customs, in order to regulate and control the entry of medical devices and products prior reaching the Saudi market to ensure that the medical devices / products are satisfying the worldwide standards and meet the national requirements requested by SFDA.