Jan 21, 2022
Saudi Arabia
The first article provides a brief overview of the SFDA guidance describing the requirements healthcare providers should follow, and also describes in detail the requirements to be applied in the case of radiation-emitting devices. Table of Contents The...
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Jul 1, 2021
Saudi Arabia
The Saudi Food & Drug Authority (SFDA), the country’s agency responsible for regulations in the sphere of medical devices, has published a second version of its guidance on approval requirements for medical device advertising. The current version of the document...
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Jun 9, 2021
Saudi Arabia
The Saudi Food and Drug Administration (SFDA), the country’s regulating authority in the sphere of healthcare products, has published updated guidance on approval requirements for medical device advertising. The document is intended to provide additional...
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May 3, 2021
Saudi Arabia
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the regulatory requirements for medical devices based on Artificial Intelligence (AI) technology. In...
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Mar 19, 2021
Saudi Arabia
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the approach to be applied for bundling/grouping medical devices intended to be marketed and used in the...
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Mar 14, 2021
Saudi Arabia
The Saudi Food and Drug Authority (SFDA), the country’s agency responsible for regulation on the sphere of medical devices and other healthcare products, has published a set of guidance documents dedicated to the relationships arising with regard to the importation...
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