Mar 23, 2023
Saudi Arabia
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...
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Mar 22, 2023
Saudi Arabia
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...
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Mar 22, 2023
Saudi Arabia
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...
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Mar 2, 2023
Saudi Arabia
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...
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Feb 7, 2023
Saudi Arabia
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...
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Feb 7, 2023
Saudi Arabia
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...
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