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Confirmation Statement for Completing the Corrective Action in the Safety Alert

2022-08-03
Confirmation Statement for Completing the Corrective Action in the Safety Alert
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Risk Assessment form

2022-08-03
Risk Assessment form
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Corrective Action Implementation Plan form

2022-08-03
Corrective Action Implementation Plan form
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Saudi Arabia Hosts 26th Annual Meeting of Global Harmonization Working Party

2023-02-06

 

The Kingdom of Saudi Arabia, represented by the Saudi Food and Drug Authority (SFDA), will host the 26th Annual Meeting of the Global Harmonization Working Party (GHWP) for Medical Devices, and the scientific and technical working groups' meetings, between February 13 and 16 2023.

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SFDA Detects More Than 21,000 Medical Supplies in Violating Warehouse in Dammam

2023-01-24

Saudi Food and Drug Authority (SFDA) detected a warehouse in Dammam that stored medical supplies without obtaining a license, in addition to not complying with storage requirements.

SFDA also monitored 21,362 medical supplies stored in inappropriate conditions in the violating warehouse, closed it precautionary, and summoned those in charge of it to complete the legal procedures against them, and implement the regulations for medical devices and supplies.

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SFDA Organizes Scientific Program for Sudanese National Council for Drugs and Toxins

2023-01-24

The Saudi Food and Drug Authority (SFDA) organized a scientific program in the field of procedures for regulating medical devices and supplies for the delegation of the National Council for Drugs and Toxins in the Republic of Sudan.

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SFDA, SABIC Co-organize Workshop to Support Innovators of Medical Devices and Supplies

2023-01-16

The Saudi Food and Drug Authority (SFDA), in cooperation with the Saudi Basic Industries Corporation (SABIC), organized a workshop to discuss the strategy to support innovators in the field of medical devices and supplies 2023 in Riyadh, as part of the SABIC's "Nusaned" initiative.

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Registration for 26th GHWP Annual Meeting in Riyadh Opens

2023-01-09

Saudi Food and Drug Authority (SFDA) invites interested people in medical devices , manufacturers , and regulatory authorities to register for the 26th annual meeting of the Global Harmonization Working Party (GHWP), which is organized by the Kingdom of Saudi Arabia represented by SFDA during the period from 13 to 16 February 2023 at Crowne Plaza Hotel in Riyadh.

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(MDS – G009) Guidance for Points of Care (POC) Medical Devices Manufacturing

2024-01-25
(MDS – G009) Guidance for Points of Care (POC) Medical Devices Manufacturing
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Guidance for Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (MDS – G010)

2023-01-03
Guidance for Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (MDS – G010)
Guide
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