Saudi Arabia
The new article provides additional clarifications regarding the regulatory status of importers and distributors, as well as warehouses. Table of Contents The Saudi Food and Drug Administration (SFDA), a country’s regulatory agency in the sphere of healthcare...
FDA
The new article provides additional clarifications regarding the aspects related to specific cases when assembly reports are required or not required Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Europe
The new article describes in detail the aspects related to the existing premarket requirements and the improvement they require. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare...
FDA
The new article highlights the aspects related to the concept of commercial availability, problematic assembly situations, and temporary installations (for instance, in case one of the existing components needs to be repaired). Table of Contents The Food and Drug...
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...
FDA
The new article addresses the aspects related to the accessories and components of diagnostic x-ray equipment, including the approach to be applied with respect to compatibility matters. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
