The Saudi Food and Drug Authority (SFDA) has approved a groundbreaking, Saudi-developed medical device for marketing. This innovative tool is designed to improve the safety and efficiency of surgical procedures.
The Saudi Food and Drug Authority (SFDA) continues its efforts to regulate clinical studies for medical devices, a fundamental requirement for evaluating their safety and performance. This initiative is part of the SFDA’s regulatory and supervisory role and its commitment to strengthening its position among the world's leading regulatory authorities.
The Saudi Food and Drug Authority (SFDA) continues to drive healthcare innovation across the Kingdom of Saudi Arabia. It's doing this through a series of regulatory and technological initiatives, including advancing clinical trials, evaluating gene and cell therapies, and approving innovative medical devices. These efforts aim to enhance patient access to advanced medical technologies and position the Kingdom as a regional hub for research and innovation, aligning with Saudi Vision 2030.
The Saudi Food and Drug Authority (SFDA) has rejected a marketing authorization application in the Kingdom of Saudi Arabia for a software medical device designed to predict the likelihood of developing Type 2 diabetes within the next four years in adults over 18. This AI and machine learning-powered device, despite being marketed in some European countries, failed to meet the Kingdom's safety and efficacy requirements.
The Saudi Food and Drug Authority (SFDA) has approved the medical device marketing authorization (MDMA) for a device that uses advanced deep brain stimulation technology. The SFDA described this technology as a breakthrough in neurological therapy, as it enables physicians to adjust treatment procedures in real time based on live brain signals detected during therapy. This allows for the personalization of treatment using data and algorithms, adapting to the patient’s changing condition.
The Saudi Food and Drug Authority (SFDA) has identified a defect in some of the Dexcom Continuous Glucose Monitoring (CGM) devices. This issue prevents audio alerts from sounding when blood glucose levels fluctuate too low or too high.
The Saudi Food and Drug Authority (SFDA) has suspended imports from an international medical device and supplies manufacturer. This action is part of its ongoing regulatory efforts to verify the safety of products under its supervision circulating in the Saudi market.
Operating around the clock, the Saudi Food and Drug Authority (SFDA), through its Hajj Operations Center, serves as a central point of contact to support field teams and ensure quick responses to reports throughout the Hajj season. This dedication aligns with the Authority's commitment to safeguarding the health and safety of pilgrims, reflecting the generous care extended by our wise leadership towards the pilgrims and their unwavering concern for their comfort and well-being.
As part of the Authority's ongoing efforts to ensure the safety and well-being of pilgrims, H.E. Prof. Dr. Hisham S. Aljadhey, Chief Executive Officer of the Saudi Food and Drug Authority (SFDA), conducted a field visit to the SFDA office in Makkah. The visit aimed to assess the implementation of operational plans for the 2025 Hajj season and confirm the readiness of services provided by the Authority to support a safe and healthy pilgrimage.
