Saudi SFDA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Regulatory Framework
Regulatory Authority: Saudi Food and Drug Authority (SFDA) -- Medical Devices Sector
Key Legislation:
- Medical Devices Law (Royal Decree M/54)
- Medical Devices Executive Regulations
- MDS-REQ1: Requirements for Medical Device Marketing Authorization (MDMA)
Classification: Risk-based, 4 classes:
- Class A (low risk) | Class B (low-medium risk) | Class C (medium-high risk) | Class D (high risk)
- Classification determined by manufacturer based on intended use, risk level, invasiveness, and duration of use
Registration Pathway:
- Appoint a local Authorized Representative (AR) licensed by SFDA
- Classify the device using MDS-G008 guidance
- Prepare technical dossier per class requirements (ISO 13485 required for Class B+)
- Submit MDMA application via GHAD electronic system
- SFDA review and issuance of MDMA certificate (Arabic & English)
Key Requirements:
- Local AR mandatory for foreign manufacturers
- Arabic labeling and IFU required
- ISO 13485 certificate required for Class B and above
- Post-Market Surveillance Plan required
- UDI implementation in progress
Current Key Guidance:
Latest Updates
SFDA NCMDR Weekly Safety Update WU2628 Released for 5 July 2026
2026-07-05 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority's National Center for Medical Devices Reporting (NCMDR) has published Weekly Update WU2628, dated 5 July 2026. This report compiles recent medical device safety alerts and field safety corrective actions from manufacturers. Affected stakeholders include healthcare providers, distributors, and patients using the listed devices. All relevant parties should review the full report and implement any recommended actions promptly to ensure patient safety.
Tags: saudi_sfda, ncmdr_weekly, safety_alert, medical_devices
SFDA Hosts Workshops on Medical Device Clinical Trials and Health Tech at GHE
2026-07-03 | Saudi SFDA | Regulation Update | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) organized two specialized workshops at the Global Health Exhibition (GHE) covering clinical trial requirements for medical devices and emerging healthcare technologies. The sessions targeted manufacturers, researchers, and healthcare professionals to enhance understanding of regulatory frameworks and encourage compliant innovation. Key discussions included trial design, ethical standards, and technology integration in the medical device sector.
Tags: clinical_trials, healthcare_technologies, sfda_workshop, medical_devices, regulatory_education
SFDA Signs MoU with AAMI to Enhance Medical Device Standards
2026-07-03 | Saudi SFDA | Regulation Update | !! MEDIUM
On July 18, 2023, the Saudi Food and Drug Authority (SFDA) signed a Memorandum of Understanding with the Association for the Advancement of Medical Instrumentation (AAMI) to collaborate on medical device standards. The partnership aims to align Saudi requirements with international best practices, affecting manufacturers seeking market access. Companies should monitor for forthcoming standards updates and guidance from this cooperation to ensure ongoing compliance.
Tags: medical_device_standards, SFDA, AAMI, regulatory_cooperation
SFDA Strengthens Global Standing by Regulating Clinical Studies for Innovative Medical Devices and Supplies
2026-07-03 | Saudi SFDA | Regulation Update | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) is advancing its global regulatory position by organizing and overseeing clinical studies for innovative medical devices and supplies. This initiative aims to foster local clinical research, align with international best practices, and encourage medical device innovation within the Kingdom. Medical device manufacturers, clinical research organizations, and healthcare professionals involved in device trials will be directly affected as the authority reinforces its oversight framework.
Tags: clinical_studies, innovative_medical_devices, sfda, regulatory_oversight
SFDA NCMDR Weekly Safety Update WU2627 – Medical Device Field Safety Notices and Recalls
2026-06-28 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) National Center for Medical Devices Reporting (NCMDR) published Weekly Update WU2627 on 28 June 2026, compiling new field safety corrective actions and recalls for medical devices. Healthcare facilities and distributors should review the listed devices and affected manufacturers to identify products requiring action and implement the recommended safety measures. The update covers multiple device categories and includes details on risk mitigation steps.
Tags: saudi_sfda, ncmdr, weekly_update, safety_notice, recall
SFDA NCMDR Weekly Update (WU2626) – Medical Device Safety Alerts and Adverse Event Reports
2026-06-21 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) released Weekly Update WU2626 through the National Center for Medical Devices Reporting (NCMDR), detailing recent safety alerts, adverse event reports, and field safety corrective actions concerning medical devices in the Saudi market. Healthcare providers, importers, and manufacturers should review the listed devices and implement any recommended actions to ensure patient safety and regulatory compliance.
Tags: medical_devices, safety_alert, sfda, ncmdr, weekly_update, saudi_arabia
SFDA NCMDR Weekly Safety Update WU2625 – 14 June 2026
2026-06-14 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) National Center for Medical Devices Reporting (NCMDR) has released Weekly Update WU2625 on 14 June 2026. This report contains recent adverse event notifications, field safety corrective actions, and recall notices for medical devices marketed in Saudi Arabia. Healthcare providers and device manufacturers should review the listed affected products and implement any required risk mitigation measures as specified in the update.
Tags: saudi_fda, ncmdr, medical_device_safety, weekly_report, recall_alert
SFDA NCMDR Weekly Update WU2624 (07 June 2026) Issued
2026-06-07 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority's National Center for Medical Devices Reporting (NCMDR) has published Weekly Update WU2624 on 07 June 2026. This report summarizes recent medical device safety alerts, listing affected products and manufacturers. Healthcare providers and stakeholders should review the update to identify any necessary corrective actions or field safety notices relevant to their facilities.
Tags: saudi_fda, ncmdr, weekly_update, safety_alert
SFDA NCMDR Weekly Safety Update WU2622 (24 May 2026) Released
2026-05-24 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority's National Center for Medical Devices Reporting (NCMDR) has published Weekly Update WU2622, dated 24 May 2026. This report compiles recent field safety notices, recalls, and adverse event reports affecting medical devices registered in the Kingdom. Manufacturers, authorized representatives, and healthcare providers should review the listed alerts to identify any devices within their inventory and implement required corrective actions promptly.
Tags: sfda, ncmdr, weekly_safety_update, field_safety_notice, medical_device_recall