Recent Regulatory Changes
This section tracks regulatory changes as they occur. Content is updated when the SFDA issues new guidance, amends regulations, or changes submission requirements. Always verify against current SFDA sources.
2022 — Landmark changes
January 2022 — MDMA-1 (GHTF route) permanently cancelled
The simplified registration route based on reference country approvals (EU CE, FDA, TGA, Health Canada, PMDA) was permanently discontinued. All new MDMA applications now follow the TFA (MDMA-2) pathway with full technical file assessment.
Impact: Manufacturers who previously relied on their CE marking or FDA clearance for fast-track Saudi registration must now prepare a full technical file for every device class.
September 2022 — MDNR (Medical Device National Registry) cancelled
The simplified listing route for basic Class A non-sterile, non-measuring devices was cancelled. All devices — including low-risk Class A — must now obtain full MDMA.
Impact: No more simplified self-declaration or listing pathway exists for any device type in Saudi Arabia.
2021 — Legislative overhaul
Medical Devices Law (CoM Resolution No. 337)
The current Medical Devices Law and its Implementing Regulation replaced the Medical Device Interim Regulation, establishing the modern SFDA regulatory framework with clear alignment to EU MDR/IVDR structures.
Monitoring future changes
The SFDA issues regulatory updates through:
- Announcements on the SFDA website
- Notifications via the GHAD portal
- Industry communications distributed through ARs
Manufacturers should instruct their AR to monitor SFDA announcements actively and alert them promptly to any changes affecting registered devices.