Riyadh: The Saudi Food and Drug Authority (SFDA) organized two specialized workshops on its Digital Health Platform during the Global Health Exhibition 2025, which took place in Riyadh under the theme 'Invest in Health.' These workshops aimed to demonstrate leading regulatory practices in clinical trials for medical devices and emerging health technologies.
According to Saudi Press Agency, the first workshop, 'SFDA Clinical Trials Requirements for Medical Devices and IVDs,' offered a detailed examination of the governing requirements for clinical trials in the medical device sector. It emphasized the SFDA's essential role in ensuring device safety before market release, thereby balancing the promotion of innovation with patient protection. The workshop also showcased the authority's initiatives to align the national clinical trials framework with international standards to support innovation within the medical devices industry.
The second workshop, 'SFDA Initiatives Towards Healthcare Solutions and Patient Care,' concentrated on the regulatory framework surrounding the burgeoning field of digital health, covering AI-enabled medical devices, Software as a Medical Device (SaMD), and digital health applications. It addressed important topics such as risk assessment, software quality assurance, and algorithm performance validation. Furthermore, the workshop highlighted the SFDA's approach to backing innovative medical devices and its commitment to increasing regulatory awareness among manufacturers and innovators. This effort aims to improve the local market's ability to adopt advanced digital health solutions.