SFDA Digital Health Framework
Digital health in Saudi Arabia
Saudi Arabia's healthcare system is undergoing significant digital transformation under Vision 2030 — the Kingdom's national development plan. Digital health technologies, telemedicine, and AI-enabled medical tools are being actively promoted as part of the healthcare modernisation agenda.
The SFDA has been developing its regulatory approach to digital health in line with this transformation and international regulatory best practice.
SFDA approach to SaMD and connected devices
The SFDA regulates software and connected devices under the existing Medical Devices Law and MDS-REQ series. Specific SFDA guidance on SaMD applies IMDRF SaMD principles, including:
- IMDRF classification framework adapted to SFDA Class A–D
- Software lifecycle requirements (IEC 62304)
- Usability engineering requirements (IEC 62366)
- Cybersecurity requirements for networked and connected devices
Telehealth and remote monitoring devices
Devices used in telehealth settings — remote monitoring systems, wearable diagnostic devices, home diagnostic tools — are subject to MDMA if they meet the medical device definition. The intended purpose and user (professional or lay) are key classification factors.
Vision 2030 healthcare digital goals
Key Saudi Vision 2030 initiatives relevant to medical device manufacturers include:
- Expansion of telemedicine infrastructure
- AI adoption in diagnostic imaging and pathology
- National digital health ecosystem development
- Increased local manufacturing (in-Kingdom production incentives)