Standards, guidelines & publications

Medical devices & IVDs

Related information

All medical devices marketed in Australia must meet the requirements which are set out in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical Devices) Regulations 2002.

Australian regulatory guidelines for medical devices (ARGMD)
This document is a guide to assist sponsors and manufacturers understand the regulatory requirements for medical devices in Australia.
IVD guidance documents
Guidance documents about regulatory requirements for in vitro diagnostic medical devices (IVDs)
Device-medicine boundary products
These guidelines are to assist sponsors in determining the status of therapeutic goods that are not readily identified as medicines or devices.
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
Requirements for the assessment of medical devices containing animal material
Requirements for the assessment of medical devices containing animal material, with particular regard to the minimisation of risks relating to transmitting transmissible spongiform encephalopathies (TSEs)
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
Approved 'Conformity Assessment Bodies' for the purposes of the EC-MRA
List of entities approved by the Secretary to be 'approved Conformity Assessment Bodies' for the purposes of the EC-MRA

Web page last updated: Friday, 18 March 2011

URL: http://www.tga.gov.au/industry/devices-sgp.htm

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