Saudi Arabia
The new article describes in detail the regulatory approach the authority intends to apply with respect to x-ray equipment in terms of assembly in order to ensure the safety and proper operations of the devices. Table of Contents The Food and Drug Administration (FDA...
FDA
The article covers the key points related to the existing regulatory requirements and highlights the most important aspects to be considered by the parties involved. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
FDA
The new article addresses the aspects related to enforcement actions the authority may take, and also describes the various types of standards. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The new article highlights the aspects related to the declaration of conformity, the applicable certification requirements, and also the information to be shared by the manufacturers with other parties involved in the use of x-ray equipment. Table of Contents The Food...
Saudi Arabia
The new article highlights the aspects related to the voluntary consensus standards recognized by the authority, and also to the overlap of the two different regulatory frameworks. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
