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.
Australia
The article highlights the critical points related to the regulatory requirements for quality management system audits and certification.
Australia
The article highlights the critical points of the new classification approach to spinal implantable medical devices.
Australia
The article highlights the key points related to the regulatory status of boundary products in Australia.
