Jun 26, 2024
FDA
The new article elaborates further on the requirements to be fulfilled by the entities involved in the activity considered remanufacturing based on considerations described in the previous article.
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Jun 26, 2024
FDA
The new article provides a general overview of several examples demonstrating the way the regulatory approach described in previous articles should be applied.
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Jun 26, 2024
ARTG
The article highlights the key points related to the regulatory requirements for in vitro diagnostic (IVD) medical devices manufactured by healthcare institutions to address their internal needs.
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Jun 26, 2024
ARTG
The new article describes in detail the applicable classification rules in-house in vitro diagnostic medical devices are subject to, as well as the relevant regulatory requirements to be applied depending on the classification.
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Jun 26, 2024
Australia
The new article provides additional clarifications pertaining to specific regulatory matters associated with in-house manufactured in vitro diagnostic medical devices, including, inter alia, responsibilities of the parties involved, as well as exclusions set forth under the existing legal framework.
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