The Saudi Food and Drug Authority (SFDA) is proud to announce joining the International Medical Device Regulators Forum (IMDRF). This strategic move reflects the SFDA's commitment to fostering collaboration and alignment with international standards and practices in the regulation of medical devices, based on its Fourth Strategy, which aims to enhance international leadership.

The SFDA's membership in the IMDRF, along with its contribution of resources and expertise, enables it to play a crucial role in shaping international standards and harmonized regulatory frameworks. Key initiatives will include exchanging expertise and best practices, aligning with international standards, promoting regulatory convergence, supporting IMDRF strategies, participating in training programs, and engaging actively in IMDRF technical committees and working groups.

The SFDA's medical device sector is dedicated to enhancing innovation and regulatory excellence. This includes developing guidance documents for emerging technologies such as artificial intelligence (AI), robotics, telemedicine, and digital health solutions. Additionally, the SFDA focuses on creating guidelines for software as a medical device (SaMD), in-house IVDs, and biotechnology-based medical devices. 

The IMDRF, established in 2011, is a global forum that works to harmonize and converge international regulations governing medical devices. Its goal is to create an effective regulatory model that addresses emerging challenges and contributes to public health and safety.

By joining the IMDRF, the SFDA reaffirms its dedication to ensuring the safety and efficacy of medical devices in Saudi Arabia while contributing to a global regulatory landscape that promotes patient safety.