The article provides an overview of the applicable regulatory requirements and highlights the key points associated thereto. Table Of Contents: The Saudi Food and Drug Administration (SDFA), a country’s regulating authority in the sphere of healthcare products, has...
The article provides an overview of the regulatory requirements for clinical trials of medical devices. Table of Contents The Saudi Food and Drug Administration (SFDA), a country’s regulating authority in the sphere of healthcare products, has published...
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...
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...
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...