Upcoming Changes
This page covers known planned regulatory developments. Timelines and scope are subject to change. Verify all upcoming changes against current SFDA announcements.
UDI phasing — continued rollout
The SFDA is implementing UDI requirements in phases by device class. Higher-risk device classes (C and D) were required to comply first; lower-risk classes follow. Manufacturers of lower-risk devices who have not yet implemented UDI should check the current SFDA UDI compliance timeline on the SFDA website and prepare accordingly.
Digital health and SaMD guidance development
The SFDA is actively developing more detailed guidance on:
- Software as a Medical Device (SaMD) — clearer qualification criteria
- AI/ML-enabled devices — including Predetermined Change Control Plans (PCCPs)
- Cybersecurity requirements for connected devices
- Telehealth and remote monitoring devices
Manufacturers of software-based devices should monitor SFDA guidance publications closely in this rapidly evolving area.
GCC harmonisation developments
The GCC is progressing regulatory harmonisation across member states. Future changes may include:
- Common technical submission format for GCC-wide registration
- Mutual recognition of inspection results
- Shared vigilance and adverse event reporting platforms
Monitor GCC-level announcements through the SFDA and Saudi Health Council communications.
SFDA eServices platform enhancements
The GHAD portal is periodically updated with new features:
- Enhanced UDI submission workflows
- Improved MDMA application tracking
- Digital certificate issuance improvements
Check GHAD release notes for system updates affecting submission workflows.