The Saudi Food and Drug Authority (SFDA) organized two specialized workshops on its Digital Health Platform as part of its participation in the Global Health Exhibition 2025, held in Riyadh under the theme “Invest in Health.” The workshops aimed to highlight leading regulatory practices in clinical trials for medical devices and in digital and emerging health technologies.

The first workshop, titled “SFDA Clinical Trials Requirements for Medical Devices and IVDs,” provided a comprehensive overview of the requirements governing clinical trials for medical devices. The workshop highlighted the SFDA’s vital role in enhancing device safety prior to market release, ensuring a crucial balance between fostering innovation and protecting patients. Additionally, the Authority’s efforts to develop and align the national clinical trials framework with international standards was presented, supporting innovation across the medical devices sector.

The second workshop, titled “SFDA Initiatives Towards Healthcare Solutions and Patient Care,” focused on the regulatory framework governing the rapidly evolving field of digital health, including AI-enabled medical devices, Software as a Medical Device (SaMD), and digital health applications. It also addressed risk assessment, software quality assurance, and algorithm performance validation. Moreover, the workshop highlighted the SFDA’s pathway for supporting innovative medical devices and its efforts to raise regulatory awareness among manufacturers and innovators, thereby enhancing the local market’s readiness to adopt advanced digital health solutions.

Through its participation in the Global Health Exhibition, the SFDA reaffirmed its commitment to advancing regulatory excellence, encouraging innovation, and fostering collaboration to ensure the safety and effectiveness of medical devices in line with global best practices.