Recent Regulatory Updates & Amendments
Key recent changes
2022 — MDMA-1 (GHTF route) cancellation
From January 2022, the GHTF/MDMA-1 registration route was permanently cancelled. All new MDMA applications — and all renewals — must follow the TFA (MDMA-2) pathway with a complete technical file.
2022 — MDNR (Medical Device National Registry) cancellation
The simplified listing route for basic Class A non-sterile, non-measuring devices (MDNR) was cancelled in September 2022. All devices must now obtain full MDMA via TFA.
2021 — Medical Devices Law and Implementing Regulation
The current Medical Devices Law (CoM Resolution No. 337) and its Implementing Regulation came into effect, replacing the Medical Device Interim Regulation and establishing the modern SFDA regulatory framework aligned with EU MDR.
Monitoring for SFDA updates
The SFDA publishes regulatory updates on its official website. Manufacturers and ARs should:
- Subscribe to SFDA notifications via the SFDA website
- Monitor the GHAD portal for system and requirement updates
- Follow SFDA announcements through the AR in Saudi Arabia