Oct 13, 2023
HSA
The new article highlights the aspects related to the information to be included in the submissions with respect to manufacturing processes and sites involved. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of...
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Oct 13, 2023
FDA
The article highlights the key points related to the regulatory status of the products in question and describes the approach to be followed. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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Oct 12, 2023
FDA
The article addresses the aspects related to the existing legal framework associated with AST system devices and highlights the key points to be considered. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
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Oct 12, 2023
FDA
The article provides an overview of the regulatory requirements set forth under the existing framework and highlights the key points associated thereto. Table of Contents The FDA, the US healthcare product regulatory authority, has released a guidance document...
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Oct 12, 2023
Africa
This article highlights what CE marking is, how to obtain it, and the steps to follow to comply with EU regulations. Table of Contents Medical devices manufacturers willing to market products in the European Union (EU), must comply with the regulations established...
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