Standards, guidelines & publications (medical devices & IVDs)

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
• Medical device application processing times
  Information on processing times for conformity assessment applications, and applications for ARTG inclusion

Related guidance and standards

A C D E F H I L M O P R S T V

A

• Advice for health procurement teams about therapeutic goods and medical devices
  Guidance for procurement areas in hospitals, residential aged care and other facilities
• Application requirements for medical devices - preliminary assessment
  Applications for the inclusion of medical devices (including IVDs) in the ARTG must meet certain requirements in order to pass preliminary assessment

C

• Chlamydia, gonorrhoea and syphilis IVD self-tests
  Guidance on the TGA's expectations and requirements concerning performance and risk mitigation for IVDs intended for use as self-tests for chlamydia, gonorrhoea and syphilis
• Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices
  Guidance to assist sponsors of IVDs with clinical evidence
• Clinical performance requirements and risk mitigation strategies for HIV tests
  Guidance document for manufacturers and sponsors of HIV tests
• Comparable overseas regulators for medical device applications
  Guidance on the use of market authorisation evidence from comparable overseas regulators for medical devices
• HIV point-of-care tests: Conditions of approval for supply in Australia
  Information on conditions of approval for HIV point-of-care tests
• Custom made medical devices
  Manufacturing of custom made devices must, at a minimum, meet conformity assessment procedures regulated by the TGA
• Cyber security for medical devices and IVDs
  Cybersecurity is an important consideration for medical devices and IVD medical devices (IVDs)

D

• Declaration of Conformity for Class I non-sterile non-measuring and Class 1 in vitro diagnostic (IVD) medical devices
  Declaration of Conformity procedures for Class I medical devices and Class 1 IVDs
• 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

E

• Electronic Instructions for Use - eIFU
  Guidance for manufacturers of medical devices who may be considering supplying the instructions for use of their device in an electronic or online format

F

• First aid kits: Guidance for sponsors and manufacturers
  Regulatory requirements that apply to first aid kits, which are regulated as system or procedure packs

H

• Hepatitis B and C viruses IVD self-tests
  Guidance on TGA's expectations concerning clinical performance requirements and risk mitigations for IVDs intended to be used as self-tests for Hepatitis B and C viruses
• How to determine if your product should be included in the ARTG
  Assistance for sponsors with products included in the ARTG as Class I medical devices to decide if their products are included correctly

I

• 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)

L

• Labelling obligations
  This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations

M

• Medical Device Incident Reporting (MDIR) guide
  Sponsor guide to MDIR
• Medical device patient cards and leaflets
  Guidance explaining the requirements for the patient implant cards and patient information leaflets for manufacturers of medical devices

O

• Off-label use of medical devices: Frequently asked questions
  Answers to frequently asked questions about off-label use of medical devices.

P

• The Poisons Standard and medical devices
  Guidance explaining the labelling requirements of medical devices containing poisons
• Priority applicant guidelines for medical devices (including IVDs)
  Guidelines to assist applicants seeking a conformity assessment (priority applicant) determination or a medical devices (priority applicant) determination

R

• Real world evidence and patient reported outcomes – medical devices
  Sponsors can use many different types of evidence to demonstrate performance and safety of medical devices as real world evidence.
• Regulation of borderline disinfectants and related products with antiviral claims (including COVID-19)
  Information for sponsors and manufacturers on the regulation of antiviral claims
• Reclassification of active medical devices for therapy with diagnostic function
  Guidance to assist sponsors with reclassification of active medical devices for therapy with a diagnostic function
• Reclassification of surgical mesh devices
  Guidance to assist sponsors with the reclassification of surgical mesh devices
• Reclassification of Spinal implantable medical devices — Guidance on the transitional arrangements and obligations
  Guidance to assist sponsors and manufacturers with reclassification of spinal implantable medical devices
• Reclassification of devices used in direct contact with the heart, central circulatory system (CCS), or central nervous system
  Guidance to assist sponsors with reclassification of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS)
• Reclassification of Medical devices that administer medicines or biologicals by inhalation
  Guidance to assist sponsors with reclassification of medical devices that administer medicines or biologicals by inhalation
• Reclassification of Active implantable medical devices (AIMD)
  Guidance to assist sponsors with reclassification of active implantable medical devices (AIMD)
• Reclassification of Medical devices that are substances introduced into the body via body orifice or applied to the skin
  Guidance to assist sponsors with reclassification of medical devices that are substances for introduction into the body
• Reduction of assessment fees for medical devices
  Eligibility requirements and procedures to determine whether assessment fees can be reduced
• Regulation of Software as a Medical Device
  Updated information on the regulation of Software as a Medical Device
• 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)

S

• Seasonal Influenza IVD self-tests
  Guidance on TGA's expectations concerning clinical performance requirements and risk mitigation for IVDs intended to be used as self-tests for seasonal influenza
• Specimen collection swabs
  All collection swabs are medical devices, and must be included in the ARTG
• Standards orders and medical devices
  Non-mandatory medical device standards orders (MDSO) and conformity assessment standards orders (CASO)
• System or procedure packs: Guidance for sponsors, manufacturers and charities
  Regulatory requirements that apply to system or procedure packs, including those supplied using the special conformity assessment procedure

T

• TGA-NATA MoU relating to the regulation of in-house IVDs
  This MoU describes the respective roles and responsibilities of the TGA and the National Association of Testing Authorities (NATA) in relation to the regulation of in-house IVDs
• 3-D printing (additive manufacturing) of medical devices
  Information for manufacturers to assist them with addressing risks and meeting the Australian regulatory requirements for medical devices

V

• Varying entries in the ARTG - medical devices and IVDs
  Guidance for sponsors: when any information included in the ARTG has changed, the relevant sponsor should consider asking the TGA to vary the ARTG entry