Saudi Arabia Medical Device Regulations |RIMS Resources

Mar 23, 2023

SFDA Guidance on Establishment Licensing: Manufacturers and Authorized Representatives

The new article highlights the aspects related to the obligations and responsibilities of medical device manufacturers and their authorized representatives. Table of Contents The Saudi Food & Drug Authority (SFDA), the country’s regulatory agency in the sphere of...

SFDA Guidance on Establishment Licensing: Overview

Mar 22, 2023

Saudi Arabia

SFDA Guidance on Establishment Licensing: Overview

The document highlights the key points associated with the licensing requirements for medical device establishments. Table of Contents The Saudi Food and Drug Authority (SFDA), a country’s regulatory agency in the sphere of healthcare products, has published a...

FDA Assembler’s Guide On Diagnostic X-Ray Equipment: Reporting And Changes

Mar 22, 2023

Saudi Arabia

FDA Assembler’s Guide On Diagnostic X-Ray Equipment: Reporting And Changes

The new article describes in detail the regulatory approach the authority intends to apply with respect to x-ray equipment in terms of assembly in order to ensure the safety and proper operations of the devices. Table of Contents The Food and Drug Administration (FDA...

FDA Guidance on X-Ray Imaging Devices: Applicable Standards and Regulatory Overlap

Mar 2, 2023

Saudi Arabia

FDA Guidance on X-Ray Imaging Devices: Applicable Standards and Regulatory Overlap

The new article highlights the aspects related to the voluntary consensus standards recognized by the authority, and also to the overlap of the two different regulatory frameworks. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...

SFDA Guidance on AI/ML-based Medical Devices: QMS

Feb 7, 2023

Saudi Arabia

SFDA Guidance on AI/ML-based Medical Devices: QMS

The new article addresses the aspects related to the quality management system in the context of medical devices based on innovative technologies. Table of Contents The Saudi Food & Drug Authority (SFDA), a country’s regulatory agency in the field of healthcare...

SFDA Guidance on AI/ML-based Medical Devices: Risk Management

Feb 7, 2023

Saudi Arabia

SFDA Guidance on AI/ML-based Medical Devices: Risk Management

The new article highlights the aspects related to managing the risks associated with medical devices based on novel technologies. Table of Contents The Saudi Food & Drug Authority (SFDA), a country’s regulatory agency in the field of healthcare products, has...

RegDesk Regulatory Roundup

SFDA Guidance on Establishment Licensing: Manufacturers and Authorized Representatives

SFDA Guidance on Establishment Licensing: Overview

FDA Assembler’s Guide On Diagnostic X-Ray Equipment: Reporting And Changes

FDA Guidance on X-Ray Imaging Devices: Applicable Standards and Regulatory Overlap

SFDA Guidance on AI/ML-based Medical Devices: QMS

SFDA Guidance on AI/ML-based Medical Devices: Risk Management

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