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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.

Other News

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)
Guide
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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)
Requirement
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Guidance on Medical Devices Classification (MDS – G008)

2022-12-13
Guidance on Medical Devices Classification (MDS – G008)
Guide
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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)
Requirement
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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


Other Warnings

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.

Other News

SFDA Monitors 274 Violations During 4,891 Inspection Tours in August

2022-09-27

Saudi Food and Drug Authority (SFDA) monitored 274 violations in facilities under its supervision, during 4,891 inspection tours in all regions of the Kingdom of Saudi Arabia in August this year.

Other News

SFDA Participates in IMDRF Meeting

2022-09-15

The Saudi Food and Drug Authority (SFDA) participated in the annual meeting of the International Medical Device Regulators Forum (IMDRF) which was held virtually for three days and hosted by the Therapeutic Goods Administration (TGA).

SFDA was represented by the Vice President for Medical Devices Sector at SFDA and Chairman of Global Harmonization Working Party (GHWP), Eng. Ali Al-Dalaan.

Other News

Mammography Dose Data Collection Sheet

2022-10-12
Mammography Dose Data Collection Sheet
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