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Guidance for ISO 13485 Requirements and Corresponding SFDA-MDS Requirements (MDS-G024)

2025-03-25
Guidance for ISO 13485 Requirements and Corresponding SFDA-MDS Requirements (MDS-G024)
Guide
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The SFDA, in collaboration with Municipalities and Commerce Ministries, Intensify Inspections in Mecca and Al Madinah to Ensure Product Safety During Ramadan and in Preparation for Hajj

2025-03-14

The Saudi Food and Drug Authority (SFDA), in collaboration with the Ministry of Municipalities and Housing and the Ministry of Commerce, is intensifying oversight and inspection visits in the Mecca and Al Madinah Provinces.

This concerted effort is part of comprehensive inspection activities conducted throughout the month of Ramadan. It builds on ongoing initiatives aimed at upholding the highest standards of safety and quality, thereby protecting consumers, pilgrims, and visitors to the Two Holy Mosques.

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Ensuring Pilgrim Safety: SFDA's Rigorous Hajj Preparation Initiatives

2025-03-20

To ensure the health and safety of pilgrims, the Saudi Food and Drug Authority (SFDA) is intensifying its preparations for the Hajj season by implementing training initiatives and engaging in collaborative scenario exercises that enhance rapid response capabilities to health incidents. Notably, during the holy month of Ramadan, the SFDA played an active role at the National Crises and Disasters Control Center at Mina Hospital, strengthening coordination among relevant government bodies and supporting preventative measures.

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Statistical Report for Conformity Assessment Bodies Inspections 2024

2025-03-18
Statistical Report for Conformity Assessment Bodies Inspections 2024
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Statistical Report for Medical Devices Manufacturers Inspections 2024

2025-03-18
Statistical Report for Medical Devices Manufacturers Inspections 2024
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Guidance on Companion Diagnostic IVDs (MDS-G026)

2025-03-23
Guidance on Companion Diagnostic IVDs (MDS-G026)
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The Saudi FDA Joins Global Regulators at 27th International Medical Device Regulators Forum (IMDRF) in Tokyo

2025-03-11

The Chief Executive Officer of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, led the SFDA’s delegation at the 27th Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF) in Tokyo, Japan, from March 10-14, 2024.

This participation follows the SFDA's recent membership in the IMDRF in September 2023, reinforcing its commitment to enhancing its international and regional leadership in medical device regulation.

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 SFDA CEO Strengthens Saudi-EU Trade and Regulatory Cooperation in High-Level Brussels Meetings

2025-02-17

In a major step toward advancing Saudi-European trade and regulatory collaboration, H.E. Dr. Hisham S. Aljadhey, Chief Executive Officer of the Saudi Food and Drug Authority (SFDA), held high-level meetings today with H.E. Luigi Di Maio, European Union (EU) Special Representative for the Gulf Region, and Dr. Sabine Weyand, Director General of the EU Directorate-General for Trade. Saudi Ambassador to the EU, Ms. Haifa Al Jedaie, was also present, reinforcing the Kingdom’s commitment to deepening economic and regulatory ties with the EU.

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Export Permission Application Form (commercial)

2022-02-09
Export Permission Application Form (commercial)
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CEO of SFDA Discusses “Regulatory Pathways: Balancing Innovation and Safety” at the Global Healthspan Summit 2025

2025-02-04

The Chief Executive Officer of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, contributed his insights to a prominent panel discussion on “Regulatory Pathways: Balancing Innovation and Safety” at the Global Healthspan Summit 2025 in Riyadh on Tuesday. The session centered on the pivotal role of regulatory frameworks in fostering innovation while ensuring public safety, particularly in efforts to extend healthy lifespans.

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