Saudi Food and Drug Authority (SFDA) was established under the Council of Ministers resolution no. (1) Issued on 10/3/2003, as an independent Authority reporting to the Council of Ministers.
The SFDA aims to “ensure the safety of food, safety, quality and effectiveness of drug, and the safety, quality, effectiveness and performance of medical devices according to their intended purpose.
Regulating medical devices, in vitro- diagnostic devices, prescription eye glasses, contact lenses and their solutions, are among the responsibilities of SFDA in accordance with its law issued by the royal decree No.(M/6) issued on 13/2/2007. Based on the Council of Ministers resolution no. (181) issued on 18/6/2007, that gave SFDA the right to issue regulations for medical devices registration rules and procedures, the SFDA issued a medical devices interim regulation, which was adopted by SFDA board of director’s decision no.(1-8-1429) issued on 27/12/2008. This regulation will apply until the medical devices comprehensive law is approved