FDA
The article provides an overview of the regulatory approach to be applied concerning certain regulatory matters.
Canada
The new article describes in detail the recall process, highlighting the most important aspects associated with it.
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.
