Mar 14, 2023
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...
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Mar 6, 2023
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...
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Mar 6, 2023
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...
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Mar 6, 2023
FDA
The new article addresses the matters related to labeling requirements the devices should comply with in order to be allowed for marketing and use in the country. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
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Mar 2, 2023
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...
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