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SFDA CEO Inspects Hajj Preparedness Across Facilities and Operational Sites in the Makkah and Eastern Regions

2026-05-08

H.E. Dr. Hisham S. Aljadhey, CEO of the Saudi Food and Drug Authority (SFDA), conducted a field inspection tour of several SFDA facilities and operational sites in the Makkah and Eastern Regions as part of the intensive preparations for this year’s Hajj season. The tour aimed to enhance the efficiency of regulatory procedures and ensure the safety of incoming products, contributing to safeguarding the health and safety of pilgrims.

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Guidance on Bundling Criteria for Medical Devices within a Single MDMA Application (MDS – G028)

2026-05-05
Guidance on Bundling Criteria for Medical Devices within a Single MDMA Application (MDS – G028)
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Statistical Report for Medical Devices Manufacturers Inspections 2025

2026-03-12
Statistical Report for Medical Devices Manufacturers Inspections 2025
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SFDA Reports 18% Growth in Licensed Factories and Warehouses During 2025

2026-01-26

The Saudi Food and Drug Authority (SFDA) recorded significant growth in the number of licensed factories and warehouses during 2025, achieving a 18% increase compared to 2024. This growth reflects the ongoing development of the regulatory environment, the empowerment of the industrial sector, and the expansion of investment support within the SFDA’s scope of work.

According to official statistics, the total number of licensed facilities reached 9,155 in 2025, up from 7,750 in 2024.

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SFDA Organizes Two Specialized Workshops on Clinical Trials and Healthcare Technologies in the Medical Devices Sector at GHE

2025-10-30

The Saudi Food and Drug Authority (SFDA) organized two specialized workshops on its Digital Health Platform as part of its participation in the Global Health Exhibition 2025, held in Riyadh under the theme “Invest in Health.” The workshops aimed to highlight leading regulatory practices in clinical trials for medical devices and in digital and emerging health technologies.

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SFDA Approves Innovative Biotechnology-Based Diagnostic Test for the Early Detection of Alzheimer's Disease

2025-09-01

The Saudi Food and Drug Authority (SFDA) has approved an innovative biotechnology-based in vitro diagnostic test designed to aid in early detection of Alzheimer's disease by measuring a specific biomarker in blood plasma. This test represents a groundbreaking advancement in medical laboratory diagnostics, significantly enhancing the early detection of neurodegenerative diseases.
Introducing a Faster and More Accurate Diagnostic Solution

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SFDA Signs a MoU with AAMI: Partnering to Advance Medical Device Standards

2025-08-20

The Saudi Food and Drug Authority (SFDA) has signed a Memorandum of Understanding (MoU) with the Association for the Advancement of Medical Instrumentation (AAMI). The agreement aims to strengthen cooperation between the two organizations in the field of medical devices, focusing on advanced technologies such as artificial intelligence and biotechnology for diagnosis and treatment. 

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Saudi Innovation in Surgery: SFDA Grants Marketing Authorization for a Saudi-Made Medical Device

2025-08-17

The Saudi Food and Drug Authority (SFDA) has approved a groundbreaking, Saudi-developed medical device for marketing. This innovative tool is designed to improve the safety and efficiency of surgical procedures.

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Guidance on Digital Health Products (MDS-G027)

2025-08-11
Guidance on Digital Health Products (MDS-G027)
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SFDA Strengthens Global Standing Through Regulation of Medical Device Clinical Studies

2025-07-28

The Saudi Food and Drug Authority (SFDA) continues its efforts to regulate clinical studies for medical devices, a fundamental requirement for evaluating their safety and performance. This initiative is part of the SFDA’s regulatory and supervisory role and its commitment to strengthening its position among the world's leading regulatory authorities.

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