Mar 23, 2023
FDA
The new article pays special attention to the situations when reports of assembly are not required and also provides additional recommendations regarding their content. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
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Mar 23, 2023
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...
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Mar 23, 2023
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...
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Mar 23, 2023
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...
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Mar 22, 2023
Thailand
The new article highlights the aspects related to management review, as well as the requirements for personnel, premises, and cleanliness as set forth by the draft regulation on criteria and good methods for distributing medical devices. Table of Contents The Thai...
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