Sep 26, 2023
Asia
The new article addresses aspects related to the way conformity to the applicable Essential Principles should be demonstrated and also outlines the key points to be considered when providing a general device description. Table of Contents The Health Sciences Authority...
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Sep 22, 2023
Asia
The present article provides an overview of the most important aspects related to submissions for in vitro diagnostic medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has...
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Sep 21, 2023
United States
The new article highlights the aspects related to compensation for participation in a clinical investigation, contact details to be communicated by study participants, and also the voluntary nature of participation and subjects’ rights associated thereto. Table...
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Sep 21, 2023
United States
The new article highlights the aspects related to the marketing applications related to the products incorporating software submitted under the various legal frameworks. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
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Sep 21, 2023
United States
The new article highlights aspects related to the description of the software to be included in submissions associated with a medical device using it. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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