Australia
The article outlines the key requirements in the context of exporting certain medical devices from Australia.
Australia
The new article provides additional details on the application process to be followed by the entities interested in designation as conformity assessment bodies, as well as the assessment process associated thereto.
Australia
The article outlines the key points associated with the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in Australia.
Australia
The new article describes certain specific aspects related to the regulatory framework for the designation of conformity assessment bodies in terms of regulatory requirements applicants should meet.
Australia
The article highlights the key points related to the regulatory framework for conformity assessment bodies designated to undertake the relevant procedures in Australia.
Australia
The article provides an overview of the official notice describing the changes to the Australian regulatory framework for medical devices.
