SFDA CEO: Saudi Arabia Has an Integrated Ecosystem Designed To Enable Emerging Medical

The CEO of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, participated in the 30th Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF). Held from 14–18 September in Singapore, the meeting was hosted by Singapore’s Health Sciences Authority (HSA).

During a panel session, Dr. Aljadhey joined the Chief Executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Chief Executive Officer of Singapore’s HSA to discuss approaches for understanding regulatory differences and expanding opportunities for convergence in medical device oversight.

Dr. Aljadhey stated that as medical technology is evolving rapidly, it is becoming increasingly important to foster greater global cooperation among regulatory authorities to ensure timely access to innovation while maintaining the highest standards of safety, effectiveness, and quality. He emphasized that no regulatory authority can—or should—operate in isolation.

The SFDA CEO explained that Saudi Arabia has an integrated ecosystem designed to enable emerging medical technologies. Built in accordance with international best practices, this system leverages advanced digital infrastructure, trusted data governance, and forward-looking frameworks for AI and cybersecurity. Through regulatory sandboxes and dedicated innovation pathways, these elements work together to transform promising concepts into safe, effective medical solutions capable of being deployed and scaled.

Dr. Aljadhey noted that the SFDA maintains a proactive, risk-based, data-driven, and lifecycle-oriented system, while strengthening pathways for emerging technologies, including innovative medical devices and AI-enabled applications, and deploying these technologies within its own regulatory processes.

He further emphasized that the IMDRF serves as an essential platform for early dialogue among regulatory authorities, helping clarify regulatory requirements for innovators, reduce unnecessary duplication, and—most importantly—strengthen scientific decision-making to support innovation and protect public health.

The International Medical Device Regulators Forum (IMDRF) is one of the most prominent international bodies dedicated to regulatory convergence in the medical device sector, bringing together leading regulatory authorities biannually to exchange best practices and establish harmonized regulatory frameworks.