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.
Australia
The new article provides an overview of the regulatory procedures associated with the changes to sponsorship in the context of medical devices intended to be marketed and used in Australia.
Australia
The article provides an overview of a checklist outlining the main principles to be considered with respect to medical devices intended to be marketed and used in Australia.
Australia
The article describes the recall procedures to ensure the continued safety of medical devices and other therapeutic products allowed for marketing and use in Australia.
