
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 18, 2023
Asia
The new article highlights the aspects related to the documentation to be provided by the medical device manufacturer with respect to the product subject to review in terms of its description, as well as testing, verification, validation activities, and conformity to...
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Sep 14, 2023
FDA
The new article highlights the aspects related to the determination of study duration, and also to the approach to be followed in order to mitigate the risks associated with missing data. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
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Aug 16, 2023
Asia
The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...
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Mar 30, 2023
Asia
The document describes in detail the aspects to be taken into account when preparing a site master file. Table of Contents Introduction The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance...
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