SFDA Medical Device Regulations and Mandatory MDMA Registration
The Saudi Food and Drug Authority (SFDA) regulates medical devices under the Medical Devices Law (Royal Decree M/54, 2017) and the associated MDS-REQ guidance series. All medical devices must obtain a Medical Device Market Authorization (MDMA) before they may be lawfully sold or imported into Saudi Arabia.
Key features of the Saudi regulatory framework:
- Risk-based classification: Class A (lowest), B, C, D (highest) — broadly aligned with GHTF/IMDRF principles.
- MDMA pathways: Full registration for most Class C and D devices; abbreviated review (TFA — Third Party Approval) for devices already approved by recognised reference authorities (FDA, CE, TGA, Health Canada, PMDA).
- GHAD Portal: The SFDA's unified electronic platform for all MDMA applications, correspondence, and post-market notifications.
- Authorised Representative (AR): All foreign manufacturers must appoint a Saudi-based AR registered with SFDA.
- ISO 13485: Mandatory QMS certification from a recognised Conformity Assessment Body (CAB) for Class B, C, and D devices.
📅 Effective / published: 2017 (Medical Devices Law); ongoing guidance updates via MDS-REQ series
Manufacturers holding CE marks, FDA clearances, or other recognised approvals should assess TFA pathway eligibility as this can significantly reduce review timelines. Ensure your Saudi AR is in good standing with SFDA and has valid AR registration before submitting through GHAD.
View official source (SFDA — Medical Devices) ↗