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.
Australia
The article overviews the legal framework for medical device systems and procedure packs intended to be marketed and used in Australia.
Australia
The new article describes in detail the key points related to the regulatory requirements applicable to the specific groups of products, namely medical systems and procedure packs.
Australia
The new article clarifies the particular conformity assessment procedure to be applied in the context of medical device systems and procedure packs.
Australia
The new article describes some aspects related to the information accompanying the products.
It provides additional clarifications regarding the parties’ obligations as set forth under the existing legal framework.
