Software as a Medical Device (SaMD) — Overview
SFDA regulatory framework for Software as a Medical Device (SaMD) — when software is a medical device, classification, and registration.
SFDA Digital Health Framework
Overview of the SFDA's approach to digital health, connected devices, telehealth, and the Saudi healthcare digital transformation under Vision 2030.
AI/ML-Enabled Devices
SFDA's current approach to AI and machine learning-enabled medical devices — classification, technical file requirements, and Predetermined Change Control Plans.
Cybersecurity Requirements for Connected Devices
SFDA cybersecurity expectations for networked and connected medical devices — risk management, technical controls, and the regulatory framework.