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.
SAHPRA
The new article highlights the aspects related to the costs associated with establishment licenses, and supporting documentation interested parties should submit, and also explains cooperation between different regulating authorities and bodies.
BfArM
The new article highlights the aspects related to the timeframes the applicants should follow.
FDA
The article provides a general overview of the guidance document issued by the US authority and highlights the key points related to the existing legal framework.
SAHPRA
The article highlights the key points related to the licensing regime for medical device establishments.
