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 22, 2023
MHRA
The article provides a general overview of the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in the United Kingdom. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK...
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Sep 22, 2023
Australia
The article provides an overview of the new classification approach adopted in Australia with respect to implantable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian healthcare product regulatory authority, 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
Australia
The new article describes in detail the approach to be applied with respect to the changes to existing entries due to the new classification rules. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
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