Saudi Arabia
The article provides an overview of the regulatory requirements for innovative medical devices intended to be marketed and used in Saudi Arabia. Table of Contents The Saudi Food & Drug Authority (SFDA), the country’s regulatory agency in the...
Saudi Arabia
The second article provides additional details regarding the use of radiation-emitting equipment and radioactive materials. Table of Contents The Saudi Food and Drug Administration (SFDA), the country’s regulatory agency in the sphere of healthcare...
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...
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...
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...
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...
