ABSTRACT
The regulatory information contained is intended for market planning and is subject to change frequently. Translations of laws and regulations are unofficial. 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. Saudi Arabia has a highly sophisticated healthcare facilities system associated with 390 hospitals occupying more than 54,000 beds, 2037 primary healthcare centers, 175 artificial kidney centers and approximately 217 private medical centers. In accordance with the Food and Drug Authority law issued by the royal decree on the 13/02/2007, which gave the Food and Drug Authority the responsibility to regulate medical devices in Saudi Arabia. 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.
