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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