ABSTRACT
The Kingdom of Saudi Arabia (KSA) is a leading country in economy and an influential market among Middle East, North Africa, and The Gulf Cooperation Council. The Saudi Arabian Government established a medical device regulation to comply with the revolution of medical devices technology and to safe guard the public health of Saudi Arabia. The main objectives of the medical device law are to protect and maintain public health within the 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 medical devices law.
