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.
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.
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.
HPRA
The new article describes in detail the requirements in-house IVDs are subject to.
HPRA
The new article elaborates more on the specific frameworks applicable to in-house IVDs allowed for manufacture and use in Ireland.
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