In accordance with the Food and Drug Authority(SFDA) law issued by the royal decree (M/6) on the 25/ 01/1428 which gave the Saudi Food and Drug Authority the responsibility to regulate medical devices in Saudi Arabia. The council of ministers decision No.181 issued on 3/6/1428 came to stress the importance of regulating medical devices which relate directly to human health .

In the last few years, the Saudi health services have grown tremendously. There are over 390 hospitals occupying more than 54,000 beds, 2037 primary healthcare centers, 175 artificial kidney centers and approximately 217 private medical centers. As well as , an increased, number of newly opened hospitals and health centers both in the public and the private sector. In consequently, the Saudi Arabian medical devices market is growing rapidly, thus, the presence of a regulatory body is important to ensure safety, quality and effectiveness of medical devices throughout their life cycle (pre-market, on-market and post-market).

The main objectives of the Medical Devices Sector (MDS) at SFDA are to protect and maintain public health within the Kingdom of Saudi Arabia (KSA) by the implementation of provisions ensuring a high level of safety and health protection of patients, users and third parties with regard to the use of medical devices as it relates to their manufacture, supply and use during their lifecycle and to mandate measures, and allocate responsibilities, to ensure that medical devices placed on the market and/or put into service within the KSA comply with all relevant requirements and provisions of the Saudi Food and Drug Authority according to the Medical devices Interim Regulation and its implementing rules.