Therapeutic Goods (Medical Devices) Regulations 2002

The Therapeutic Goods (Medical Devices) Regulations 2002 set out the requirements for the registration, classification, and conformity assessment of medical devices in Australia.

Official version of legislation
The Federal Register of Legislation is the authorised Australian Government website for Commonwealth legislation. It contains the full text and details of the life cycle of individual laws.

The Therapeutic Goods (Medical Devices) Regulations 2002 were established under the Therapeutic Goods Act 1989.

These regulations set out the requirements for the registration, classification, and conformity assessment of medical devices in Australia.

They aim to protect public health and safety by ensuring that medical devices meet essential standards before they can be marketed and used.

Read the legislation

Guidance referring to this legislation

Complying with the Unique Device Identification timeframes for medical devices

22 May 2026

Guidance

Timeframes for supplying UDI compliant medical devices in Australia
Preparing for an application audit for in-vitro diagnostic medical devices

12 May 2026

Guidance

Guidance for preparing a technical file review, as part of your application to include an in-vitro medical device (IVD) in the Australian Register of Therapeutic Goods.
Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs)

11 May 2026

Guidance

This guidance explains how overseas assessments can support our medical device certification and registration processes.
Using assessments from comparable overseas regulators for medical devices

11 May 2026

Guidance

Guidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.
Understanding the health facility management software exclusion

16 March 2026

Guidance

Guidance on when software used for the administration or management of health processes or facilities may be excluded from our regulatory requirements.
Understanding the communications software exclusion

16 March 2026

Guidance

Guidance on when software that enables communications to support the delivery of health services may be excluded from our regulatory requirements.
Understanding the general health or wellness software exclusion

16 March 2026

Guidance

Guidance on when consumer software products that promote general health or wellness may be excluded from our regulatory requirements.
Understanding the image storage and transmission software exclusion

16 March 2026

Guidance

Guidance on when software products with the sole purpose of storing or transmitting patient images may be excluded from our regulatory requirements.
Understanding the clinical workflow management software exclusion

16 March 2026

Guidance

Guidance on when software used for clinical workflow management may be excluded from our regulatory requirements.
Understanding the electronic health records software exclusion

16 March 2026

Guidance

Software or a combination of software and hardware that is an electronic health record (EHR) may be excluded from our regulatory requirements.
Understanding the middleware for health systems exclusion

16 March 2026

Guidance

Guidance on when software that is middleware intended to connect or interface applications may be excluded from our regulatory requirements.
Understanding the calculator software exclusion

16 March 2026

Guidance

Guidance on when software that makes calculations may be excluded from our regulatory requirements.
Understanding the population-based analytics software exclusion

16 March 2026

Guidance

Guidance about when certain types of population-based analytics software may be excluded from our regulatory requirements.
Understanding the laboratory information management software exclusion

16 March 2026

Guidance

Guidance about when certain types of laboratory information management systems (LIMS) and laboratory information systems (LIS) may be excluded from our regulatory requirements.
Understanding when health alert software systems qualify for exclusion

16 March 2026

Guidance

Guidance on when software that provides alerts to health professionals in relation to patient care may be excluded from our regulation.
Understanding the health self-management software exclusion

16 March 2026

Guidance

Guidance on when software products for consumers to self-manage an existing disease or health condition may be excluded from our regulatory requirements.
Understanding the behavioural change or coaching software exclusion

16 March 2026

Guidance

Guidance on when consumer software products that encourage behavioural change to improve general health or wellness may be excluded from our regulations.
Understanding the patient survey software exclusion

16 March 2026

Guidance

Guidance on when software used as a patient reported outcome measures (PROMs) questionnaire or patient survey may be excluded from our regulation.
Understanding the digital mental health tool software conditional exclusion

16 March 2026

Guidance

Guidance on when consumer software products like apps or websites intended to support users' mental health are excluded from our regulatory requirements.
Understanding your post-market responsibilities for medical devices

12 March 2026

Guidance

Guidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
Use of legislative powers related to recalls and other market actions

24 February 2026

Guidance

Guidance to help sponsors understand the legislative powers the TGA can use relating to market actions.
Understanding how we regulate software-based medical devices

24 February 2026

Guidance

Guidance on how we regulate software-based medical devices.
Manufacturing and supplying surgical loan kits to Australian hospitals

18 February 2026

Guidance

Understand your role and obligations when manufacturing surgical loan kit components, assembling surgical loan kits, or supplying surgical loan kits to hospitals in Australia.
Understanding clinical decision support system software regulation

29 January 2026

Guidance

Guidance about how Clinical Decision Support System (CDSS) software is regulated. Find out when this software is exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG).
Applying for an export certification for medical devices

19 January 2026

Guidance

This guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).
Becoming an authorised prescriber for unapproved therapeutic goods in Australia

23 December 2025

Guidance

Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.
Complying with the Essential Principles on the safety and performance of medical devices

20 November 2025

Guidance

Guidance on how medical devices must comply with the Essential Principles.
Instructions for disinfectant testing

7 November 2025

Guidance

Guidance on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104.
Complying with medical device cyber security requirements

2 October 2025

Guidance

Guidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.
Understanding selection criteria for medical device application audits

25 September 2025

Guidance

Guidance for sponsors of medical devices seeking to include a medical device (including in vitro diagnostic devices) in the Australian Register of Therapeutic Goods (ARTG).
Understanding the medical device application audit process

25 September 2025

Guidance

This guidance is for sponsors of applications for inclusion of medical devices, including in vitro diagnostic (IVD) devices, in the Australian Register of Therapeutic Goods (ARTG).
Meeting 3D printing (additive manufacturing) rules for medical devices

20 August 2025

Guidance

Guidance for manufacturers to help you manage risks and meet regulatory requirements.
Preparing for Good Clinical Practice (GCP) inspections

2 July 2025

Guidance

Guidance on GCP inspections for clinical trial sites of investigational biologicals, medicines and medical devices regulated under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes.
Understanding regulatory requirements for in vitro diagnostic (IVD) companion diagnostics (CDx)

13 May 2025

Guidance

Guidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or biological that requires CDx testing.
Understanding regulation of custom-made medical devices

7 May 2025

Guidance

Guidance for manufacturers and sponsors (including health professionals) on how we define and regulate custom-made medical devices (CMMDs).
Understanding specified articles and excluded products in personalised medical devices regulation

7 May 2025

Guidance

Guidance for manufacturers and sponsors of personalised medical devices, including health professionals. Learn what we mean by ‘specified articles’ and the difference between exempt vs excluded products.
Understanding requirements for medical devices containing medicinal, microbial, recombinant or animal origin substances

6 March 2025

Guidance

This guidance explains the new regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances effective from 1 July 2024. It helps sponsors interpret the new classification rule, conformity assessment requirements and transition arrangements.
Defining joint replacement medical devices and ancillary medical devices

20 November 2024

Guidance

Guidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.
Demonstrating evidence to comply with the Essential Principles

19 November 2024

Guidance

Manufacturers are responsible for maintaining evidence that their devices comply with the Essential Principles.
Providing patient information leaflets and implant cards for medical devices

18 November 2024

Guidance

Guidance on how to provide the required patient information materials with all implantable and active implantable medical devices.
Understanding standards for face masks and respirators

12 November 2024

Guidance

Guidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion in the Australian Register of Therapeutic Goods (ARTG).
Understanding evidence requirements for market authorisation of medical devices

11 November 2024

Guidance

Guidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation.
Classifying in-vitro diagnostic medical devices (IVDs) for supply in Australia

5 November 2024

Guidance

Classifying in-vitro diagnostic medical devices (IVDs) according to the health risk that may arise from an incorrect result.
Complying with regulatory requirements for system or procedure packs

5 November 2024

Guidance

Guidance on the regulation of system or procedure packs and using the special conformity assessment procedure.
Understanding Conformity Assessment for in-vitro diagnostic medical devices

4 November 2024

Guidance

Guidance for manufacturers outlining the procedures for submitting Conformity Assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)
Classifying medical devices that are not in-vitro diagnostics (IVDs)

1 November 2024

Guidance

Guidance to help manufacturers of medical devices classify their devices correctly.
Clinical evidence guidelines for medical devices

31 October 2024

Guidance

Guidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.
Including in-vitro diagnostic (IVD) medical devices in the ARTG

28 October 2024

Guidance

Guidance for sponsors on the process for including IVD medical devices in the ARTG.
Reclassifying active medical devices for therapy with diagnostic functions

27 October 2024

Guidance

Guidance on the transitional arrangements and obligations of medical devices with a diagnostic function.
Determining if your medical device should be in the ARTG

23 October 2024

Guidance

Guidance to understand if your medical device product should be in the Australian Register of Therapeutic Goods (ARTG).
Making an offer of enforceable undertaking for compliance

23 October 2024

Guidance

Guidance for making an offer of enforceable undertaking to us.
Complying with identification requirements for medical devices that contain software

18 October 2024

Guidance

Guidance on how to interpret Essential Principle 13B and how it applies to your device.
Understanding personalised medical devices rules (including 3D-printed devices)

17 October 2024

Guidance

Guidance and examples to help you understand the regulatory framework for personalised medical devices.
Requesting the Minister for Health to reconsider our initial decision

14 October 2024

Guidance

Guidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
Manufacturing or supplying in-house in-vitro diagnostic medical devices (IVDs)

14 October 2024

Guidance

Guidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).
Clinical performance evaluation and risk management of seasonal influenza rapid antigen tests

14 October 2024

Guidance

Guidance applies to self-tests and point-of-care combo test kits.
Applying for Australian Conformity Assessment Body (CAB) determination for medical devices

11 October 2024

Guidance

Guidance for Australian corporations applying to become an Australian Conformity Assessment Body (CAB) for medical devices, including IVDs.
Supplying unapproved therapeutic goods as a sponsor

10 October 2024

Guidance

This guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.
Applying for a Conformity Assessment certificate for medical devices

9 October 2024

Guidance

An overview on the application process for manufacturers aiming to obtain a TGA-issued Conformity Assessment certificate.
Using software with COVID-19 rapid antigen self-tests

9 October 2024

Guidance

Guidance to explain what we need for software and apps that work with COVID-19 rapid antigen tests.
Applying the Advertising Code rules: prominently displayed or communicated information

4 October 2024

Guidance

This guidance explains parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.
Australian clinical trial handbook

3 October 2024

Guidance

Guidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.
Completing Conformity Assessment for immunohaematology reagents (IHRs)

2 October 2024

Guidance

Guidance on ARTG and Conformity Assessment requirements for immunohaematology reagents (IHRs).
Understanding clinical performance requirements for in-vitro diagnostic (IVD) self-tests for hepatitis B and C

2 October 2024

Guidance

Guidance on clinical performance requirements and risk mitigation strategies.
Supplying or manufacturing medical devices containing poisons

30 September 2024

Guidance

Guidance for the requirements applicable to medical devices containing poisons.
Supplying electronic instructions for use (eIFU) for medical devices

30 September 2024

Guidance

Guidance for manufacturers of medical devices considering supplying the instructions for use of their device in an electronic or online format.
Meeting performance and safety requirements for COVID-19 in-vitro diagnostics (IVDs)

30 September 2024

Guidance

Guidance for sponsors of COVID-19 IVDs about their ongoing obligations
Understanding performance requirements and risk mitigation for COVID-19 rapid antigen tests

30 September 2024

Guidance

Guidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.
Supplying first aid kits that contain medical devices or medicines

30 September 2024

Guidance

Guidance for sponsors and manufacturers on regulatory responsibilities associated with first aid kits supplied using the special Conformity Assessment procedure.
Completing a Declaration of Conformity for Class 1 medical devices

30 September 2024

Guidance

Guidance detailing self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.
Understanding digital mental health device rules

30 September 2024

Guidance

This guidance helps providers of digital mental health services or products to understand their regulatory obligations.
Understanding rules for in-vitro diagnostic (IVD) self-tests for chlamydia, gonorrhoea and syphilis

30 September 2024

Guidance

Guidance on clinical performance and risk mitigation requirements for self‑test IVDs for chlamydia, gonorrhoea and syphilis.
Meeting clinical evidence requirements for in-vitro diagnostic (IVD) medical devices

30 September 2024

Guidance

Guidance to understand how we interpret regulations and how manufacturers can comply with them.
Exporting a ventilator

27 September 2024

Guidance

Guidance for sponsors and manufacturers about pathways for exporting a ventilator from Australia.
Understanding priority applicant determination rules for medical devices including in-vitro diagnostics (IVDs)

27 September 2024

Guidance

Guidance on the priority applicant determination criteria and process for medical devices including in vitro diagnostics (IVDs).
Reclassifying surgical mesh devices

27 September 2024

Guidance

Guidance to assist sponsors with the reclassification of surgical mesh devices.
Classifying active medical devices in Australia (including software-based medical devices)

27 September 2024

Guidance

Guidance to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.
Understanding medical device definitions and rules for system or procedure packs

26 September 2024

Guidance

Guidance for sponsors and manufacturers about medical device definitions and requirements for system or procedure packs.
Possessing and supplying vaping goods in Australia

26 September 2024

Guidance

Guidance on the application of the Therapeutic Goods (Vaping Goods - Possession and Supply) Determination 2024.
Completing a declaration of conformity for system or procedure packs

25 September 2024

Guidance

This guidance applies to manufacturers of medical devices that are regulated as system or procedure packs and supplied using the special conformity assessment procedure regulatory pathway.
Understanding your regulatory obligations for exempt medical devices

25 September 2024

Guidance

Learn the regulatory obligations for exempt medical devices in Australia, including manufacturer responsibilities, safety, record‑keeping and compliance requirements.
Meeting rules for active medical devices that use energy to operate

24 September 2024

Guidance

Guidance on the requirements that specifically apply to active medical devices.
Providing documentation for including medical devices in the ARTG

24 September 2024

Guidance

Guidance on the documents that may be required to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including In Vitro Diagnostic medical devices (IVDs).
Labelling medical devices to meet regulatory requirements

24 September 2024

Guidance

Guidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
Understanding regulation of software as in-vitro diagnostic medical devices (IVDs)

23 September 2024

Guidance

Guidance on when software is classified as an in vitro medical device and how it is regulated.
Understanding regulation of disinfectants, sterilants and sanitary products

23 September 2024

Guidance

Guidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
Meeting legal obligations for supplying COVID-19 test kits

23 September 2024

Guidance

Guidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.
Reporting adverse events for medical devices

23 September 2024

Guidance

Learn how to report adverse events for medical devices in Australia, including requirements, reporting processes, and responsibilities for sponsors and manufacturers.
Submitting annual reports for medical devices

23 September 2024

Guidance

Guidance for sponsors of certain medical devices who are required to submit annual reports.
Providing a sponsor notice to import or supply therapeutic vaping goods in Australia

10 September 2024

Guidance

From 1 March 2024, a sponsor notice must be given by a sponsor of a vaping good to the TGA before the good is imported into, or supplied in, Australia following domestic manufacture.
Understanding if changes to software-based medical device regulation affect you

3 July 2024

Guidance

Guidance about regulatory changes for software based medical devices, including software as a medical device (SaMD).
Understanding regulatory basics on medical devices for health practitioners

24 April 2024

Guidance

This guidance helps Australian health practitioners, that manufacture, supply, and use medical devices, to understand whether you are regulated by us, and how to comply.
Understanding requirements for dental practitioners when making and adapting personalised medical devices

23 April 2024

Guidance

Guidance on regulatory requirements for Ahpra registered dental practitioners making and adapting personalised medical devices for patients.
Reclassifying spinal implantable medical devices

10 January 2024

Guidance

Guidance on the transitional arrangements and obligations of sponsors and manufacturers.
Reclassifying medical devices that administer medicines or biologicals by inhalation

1 December 2023

Guidance

Guidance to assist sponsors of medical devices that administer medicines or biologicals by inhalation meet their obligations and comply with regulations
Using Global Medical Device Nomenclature (GMDN) terms for medical devices

6 September 2023

Guidance

Guidance to assist sponsors and manufacturers when applying for inclusion in the Australian Register of Therapeutic Goods (ARTG) and selecting a GMDN term.
Reclassifying active implantable medical devices (AIMD)

5 May 2023

Guidance

This guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations.
Following clinical performance and risk mitigation rules for HIV tests

18 April 2023

Guidance

Guidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations.
Understanding Conformity Assessment for in-vitro diagnostic medical devices (IVDs)

1 September 2022

Guidance

Guidance explaining sponsor requirements for IVD Conformity Assessment through manufacturer agreements and regulatory compliance.
Evaluating seasonal influenza in-vitro diagnostic (IVD) self-tests – clinical performance and risk mitigation

18 March 2021

Guidance

Guidance on clinical performance requirements and risk mitigation for in vitro diagnostic medical devices intended to be used as self-tests for seasonal influenza.
Manufacturing COVID-19 medical devices and components, including 3D printing

28 January 2021

Guidance

Guidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.

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Therapeutic Goods (Medical Devices) Regulations 2002

Official version of legislation

Guidance referring to this legislation