Jan 16, 2023
Asia
The new article highlights the key points related to reporting adverse events associated with in vitro diagnostic medical devices and also describes the applicable reporting timelines. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory...
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Jan 16, 2023
Brazil
The new article addresses the aspects related to the regulatory requirements to be applied with respect to the software products intended to be used for various purposes, including diagnosing and interaction with laboratory equipment. Table of Contents The Brazilian...
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Dec 9, 2022
Asia
The article provides an overview of the regulatory requirements in the sphere of adverse event reporting. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document...
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Dec 7, 2022
Brazil
The new article describes in detail the aspects related to the products intended to process medical records, as well as the ones based on the use of non-medical hardware platforms (smartphones). Table of Contents The Brazilian regulating authority in the sphere of...
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Dec 7, 2022
Asia
The new article covers the aspects related to the device-specific advertising requirements, as well as to the corrective measures to be taken with respect to non-compliances identified. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory...
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