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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Apr 28, 2021
Uncategorized
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority in the sphere of medical devices, has published guidance dedicated to the labeling requirements medical devices should comply with in order to be allowed for marketing and use. Regulatory...
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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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Jan 19, 2021
Saudi Arabia
The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published guidance dedicated to the requirements related to the importation of medical devices for special purposes, such as demonstration or training. The present document constitutes an amended version of...
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