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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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CEO of SFDA Meets with Mauritanian Health Minister

2022-12-26

His Excellency the CEO of the Saudi Food and Drug Authority (SFDA), Dr. Hisham bin Saad Aljadhey, met today at the authority’s headquarters in Riyadh, His Excellency the Minister of Health of the Islamic Republic of Mauritania, Moktar Ould Dahi and his accompanying delegation, in the presence of the Ambassador of the Republic of Mauritania to the Kingdom Sidi Ali.

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SFDA CEO Meets with CEOs of Medical Devices Companies

2022-12-26

His Excellency the CEO of the Saudi Food and Drug Authority (SFDA), Dr. Hisham bin Saad Aljadhey, met at the authority's headquarters with a number of CEOs of medical devices companies, as part of the program of periodic meetings with the private sector aimed at enhancing communication transparency, partnership and supporting investment.

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SFDA Participates in Annual International Meeting of ISO's Quality Management System Standards Committee for Medical Devices and Supplies

2022-12-25

The Saudi Food and Drug Authority (SFDA) has participated in the 24th Annual Meeting of the International Technical Committee for the Specifications of the Quality Management System for Medical Devices and Supplies of the International Organization for Standardization (ISO), which was held in Arlington, USA, in the presence of representatives from 25 countries.

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Guidance for the operation and use of radiation emitting medical devices (MDS – G007)

2022-12-22
Guidance for the operation and use of radiation emitting medical devices (MDS – G007)
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Requirements for Inspections and Quality Management System for Medical Devices (MDS – REQ10)

2022-07-28
Requirements for Inspections and Quality Management System for Medical Devices (MDS – REQ10)
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Guidance on Medical Devices Classification (MDS – G008)

2022-12-13
Guidance on Medical Devices Classification (MDS – G008)
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Requirements for Post-Market Surveillance of Medical Devices (MDS – REQ11)

2023-03-28
Requirements for Post-Market Surveillance of Medical Devices (MDS – REQ11)
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SFDA Issues Safety Alert for Masks Used with BiPAP and CPAP Devices

Warning Status
    فعّال
Warning Date
    2022-10-05
Manufacture Company

SFDA Issues Safety Alert for Masks Used with BiPAP and CPAP Devices

2022-10-05

The Saudi Food and Drug Authority (SFDA) issued a warning regarding the safety of devices Implanted medical devices which are affected by masks containing magnets (face and nasal masks) used with Bilevel Positive Airway Pressure (BiPAP) and Continuous Positive Airway Pressure (CPAP) medical devices, produced by the Philips Respironics factory.

  • To report sector-related issues

  • Call Centre 19999


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ISO Technical Committee for Specifications of Anaesthetic and Respiratory Equipment Endorses SFDA Proposals

2022-07-24

International Organization for Standardization (ISO) Technical Committee for Specifications of anaesthetic and respiratory equipment approved several proposals submitted by the Saudi Food and Drug Authority (SFDA), during the committee’s meetings held from July 11 to 15 in St. Johns, Canada.

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