Mar 4, 2024
United States
The article provides an overview of the reclassification process commenced by the US medical device regulatory agency.
Also, it outlines the specifics of such a process in the context of high-risk in vitro diagnostic medical devices.
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Feb 2, 2023
Australia and Oceania
The article provides an overview of the new classification rules for certain medical devices recently introduced in Australia. Table Of Contents: The guidance is intended to provide medical device manufacturers and other parties involved in manufacturing medical...
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Jan 16, 2023
Asia
The article provides an overview of the changes to the applicable classification rules with respect to a specific category of medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products,...
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May 21, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published guidance on reclassification of medical devices that administer medicines or biologicals by inhalation. The document falls within the...
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May 14, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulations, has published an official notice on the reclassification of certain medical devices. According to the document, the TGA intends to review the existing...
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