Medical Devices

Guidance on Biotechnology-based Medical Devices (MDS-G016)

2024-02-12
Guidance on Biotechnology-based Medical Devices (MDS-G016)
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SFDA Recognized Standards (Supporting Medical Device Premarket Submissions)

2024-05-21
SFDA Recognized Standards (Supporting Medical Device Premarket Submissions)
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Guidance on Medical Devices Samples Collection (MDS-G013)

2023-12-20
Guidance on Medical Devices Samples Collection (MDS-G013)
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Guidance on Saudi Food and Drug Authority Policy for Engagement with Patients (MDS-G019)

2023-11-30
Guidance on Saudi Food and Drug Authority Policy for Engagement with Patients (MDS-G019)
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Guidance on Saudi Food and Drug Authority Policy for Collection of Patient Experience Data (MDS-G018)

2023-11-30
Guidance on Saudi Food and Drug Authority Policy for Collection of Patient Experience Data (MDS-G018)
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Guidance on Saudi Food and Drug Authority Policy for Engagement with Healthcare Practitioners (MDS-G017)

2023-11-30
Guidance on Saudi Food and Drug Authority Policy for Engagement with Healthcare Practitioners (MDS-G017)
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Implementing Regulation of the Law of Medical Devices

2021-09-27
Implementing Regulation of the Law of Medical Devices
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Guidance on SFDA Requirements for Quality Assurance Programs for Radiation Emitting and Imaging Devices (MDS-G15)

2023-09-28
Guidance on SFDA Requirements for Quality Assurance Programs for Radiation Emitting and Imaging Devices (MDS-G15)
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Question

What are the requirements for the inspection of medical devices manufacturers?


Answer

Available on the link below : https://www.sfda.gov.sa/en/regulations/87120


Question

Is it possible to import used medical devices?


Answer

importation of used medical devices is not allowed


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