Device-medicine boundary products TGA advises this document is currently under review. This November 2005 version will remain available for information purposes until a revised document is published.
In vitro fertilisation (IVF) solutions Summarises requirements for IVF solutions to demonstrate compliance with the Essential Principles for safety and performance of medical devices, or the Australian Medical Device Requirements (DR4, for devices containing material of human origin)
Reduction of assessment fees for medical devices Information about the eligibility requirements and procedures used by the TGA in order to determine whether assessment fees can be reduced for application audits and conformity assessment applications involving medical devices
Standards orders and medical devices The Australian medical devcies legislation includes a system of non-mandatory medical device standards orders (MDSO) and conformity assessment standards orders (CASO) that can be used to demonstrate compliance with the Essential Principles or Conformity Assessment Procedures