Sep 28, 2023
Australia
The article highlights the aspects related to the regulatory framework for telecommunication products, radiation-emitting medical devices as well as the software used to power healthcare products. Table of Contents The Therapeutic Goods Administration (TGA), an...
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Sep 26, 2023
Australia
The new article highlights the aspects related to Class IIb spinal implantable medical devices and also highlights some other points related to the recent changes to the applicable classification rules impacting the regulatory status of spinal implantable medical...
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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
MHRA
The new article highlights aspects related to the in-house manufacture of in vitro diagnostic medical devices. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products,...
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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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