Medical Devices

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)
Guide
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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)
Guide
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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)
Guide
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Implementing Regulation of the Law of Medical Devices

2021-09-27
Implementing Regulation of the Law of Medical Devices
List
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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)
Guide
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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


Guidance on the Procedures for Licensing of Medical Devices and Supplies Establishments

2024-01-22
Guidance on the Procedures for Licensing of Medical Devices and Supplies Establishments
Guide
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Checklist for Quality Manual Form

2023-08-06
Checklist for Quality Manual Form
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Guidance on Content of Labeling of Contact Lenses and its Solutions (MDS-G14)

2024-10-01
Guidance on Content of Labeling of Contact Lenses and its Solutions (MDS-G14)
Guide
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Requirements on Importation and Shipments Clearance of Medical Devices (MDS-REQ5)

2023-10-16
Requirements on Importation and Shipments Clearance of Medical Devices (MDS-REQ5)
Requirement
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