The Saudi Food & Drug Authority (SFDA) is the government agency that regulates drugs and medical devices in Saudi Arabia. It is also in charge of biological and chemical substances, as well as electronic products. The agency was established under the Council of Ministers resolution no (1) dated 07/01/1424 H and functions under the Council of Ministers as an independent body that reports to the President of Council of Ministers.
SFDA is in charge of overseeing the safety, security and effectiveness of medical devices, ensuring their accuracy, controlling and supervising manufacturing facilities as well as overseeing the importation and registration of these products.
Some of the most important regulations for medical devices in Saudi Arabia are:
- The Interim Regulatory Scheme
- National Provisions and Requirements for Medical Devices
- Implementing Rule on Establishment Registration - MDS - IR2 version 3
- Implementing Rule on Medical Devices Listing - MDS - IR3 version 4
A full list of SFDA regulations can be found here.