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)
  Regulatory requirements for medical devices in Australia
• IVD guidance documents
  Regulatory requirements for in vitro diagnostic medical devices (IVDs)
• Clinical evidence guidelines documents for medical devices
  Guidance on what constitutes clinical evidence and the process of clinical data generation and clinical evaluation to produce such clinical evidence
• Conformity assessment
  Guidance for conformity assessment applications, including changes to TGA issued conformity assessment certificates.

Related guidance and standards

• Clinical performance requirements and risk mitigation strategies for HIV tests
  Guidance document for manufacturers and sponsors of HIV tests
• Conditions of approval on the ARTG for HIV POCT
  Information on conditions of approval on the ARTG for HIV POCT
• Custom made medical devices
  Manufacturing of custom made devices must, at a minimum, meet conformity assessment procedures regulated by the TGA
• Defining joint replacement medical devices and ancillary medical devices
  Regulatory amendments defining shoulder, hip and knee joint replacement medical devices and ancillary medical devices
• Device-medicine boundary products
  This document is currently under review
• 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
  Eligibility requirements and procedures to determine whether assessment fees can be reduced
• Regulation of medical software and mobile medical 'apps'
  Software is becoming increasingly important in medical devices
• Requirements for the assessment of medical devices containing animal material
  Requirements with particular regard to the minimisation of risks relating to transmitting transmissible spongiform encephalopathies (TSEs)
• Standards orders and medical devices
  Non-mandatory medical device standards orders (MDSO) and conformity assessment standards orders (CASO)
• Varying entries in the ARTG - medical devices and IVDs
  New guidance available