Australia
The article provides an overview of the legal framework for labeling requirements applicable to medical devices intended to be marketed and used in Australia.
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.
Serbia
The article describes in detail the approach to be applied when requesting changes to the existing medical device registration.
FDA
The article highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.
HSA
The new article describes in detail the approach to be followed when applying for registration and marketing approval for Class A and B medical devices.
