Singapore hosted the 30th Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF) from 14–18 September, where Prof. Hisham Aljadhey, CEO of the Saudi Food and Drug Authority (SFDA), participated.
According to SPA, Aljadhey joined the Chief Executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Chief Executive Officer of Singapore’s Health Sciences Authority (HSA) during a panel session. The discussion focused on understanding regulatory differences and expanding opportunities for convergence in medical device oversight.
Aljadhey stated that Saudi Arabia utilizes an integrated ecosystem to enable emerging medical technologies. This system is built on international best practices and uses digital infrastructure, data governance, and frameworks for cybersecurity and AI. The SFDA employs regulatory sandboxes and innovation pathways to turn concepts into medical solutions that can be scaled and deployed.
The SFDA CEO noted that the authority uses a risk-based, data-driven, and lifecycle-oriented system. This approach strengthens pathways for AI-enabled applications and innovative medical devices, which are also deployed within the authority’s own regulatory processes. He described the IMDRF as a platform for early dialogue to clarify requirements for innovators and reduce duplication.
What is the nature of Saudi Arabia’s ecosystem for emerging medical technologies? Saudi Arabia has an integrated ecosystem designed to enable emerging medical technologies based on international best practices. This system leverages forward-looking frameworks for cybersecurity and AI, alongside trusted data governance and advanced digital infrastructure. To transform concepts into scalable medical solutions, the system utilizes dedicated innovation pathways and regulatory sandboxes.
How does the SFDA manage the regulation of innovative medical devices? The SFDA maintains a system that is data-driven, risk-based, and lifecycle-oriented. This approach is used to strengthen pathways for AI-enabled applications and innovative medical devices. Additionally, the SFDA deploys these specific technologies within its own internal regulatory processes to ensure effectiveness.
What was the purpose of the IMDRF meeting in Singapore? The 30th Management Committee Meeting of the International Medical Device Regulators Forum was hosted by Singapore’s Health Sciences Authority from 14–18 September. It served as a platform for early dialogue among regulatory authorities to clarify requirements for innovators, reduce unnecessary duplication, and discuss convergence in medical device oversight.