If you're planning to bring a medical device to market in Australia, this is your starting point.
You need to understand how we regulate these products and your obligations at each stage.
This includes:
determining whether your product meets the definition of a medical device
determining whether any exclusions or exemptions apply
choosing the correct classification
preparing evidence
meeting product standards
Being well prepared helps ensure your product meets Australian requirements and avoids regulatory delays.
Start by learning your responsibilities and the regulatory requirements that apply to your device.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all products.
General information
Learn about how products are regulated.
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PageWhen and how we regulate medical devices that are or use artificial intelligence technology.
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PageCheck your product is a medical device that needs to be included in the Australian Register of Therapeutic Goods (ARTG).
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PageLinks to information on IVD medical devices, including HIV and nutrigenetic tests.
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GuidanceGuidance for sponsors on the process for including IVD medical devices in the ARTG.
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PageFlowcharts guiding developers and users of software to decide which software and apps are medical devices.
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PageSteps to include a medical device (including IVD medical devices) in the Australian Register of Therapeutic Goods (ARTG).
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PageInformation about how we regulate medical devices and how to get your medical device approved for use in Australia.
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PageInformation to assist you with Australia's regulatory framework for medical devices, including in vitro diagnostic (IVD) medical devices.
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PageInformation about patient-matched, custom-made, and adaptable medical devices.
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PageOverview of the way we consider risks and benefits during the evaluation and post-market monitoring of products.
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PageInformation for manufactures and sponsors of medical device systems or procedure packs.
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GuidanceGuidance 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).
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GuidanceThis guidance helps providers of digital mental health services or products to understand their regulatory obligations.
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GuidanceGuidance on how we regulate software-based medical devices.
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GuidanceGuidance and examples to help you understand the regulatory framework for personalised medical devices.
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GuidanceGuidance on when software is classified as an in vitro medical device and how it is regulated.
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GuidanceThis guidance helps Australian health practitioners, that manufacture, supply, and use medical devices, to understand whether you are regulated by us, and how to comply.
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GuidanceGuidance to help sponsors understand the legislative powers the TGA can use relating to market actions.
Definitions and classification
Understand how products are defined and classified.
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PageHow medical devices are classified, including in vitro diagnostics (IVDs).
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GuidanceGuidance to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.
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GuidanceClassifying in-vitro diagnostic medical devices (IVDs) according to the health risk that may arise from an incorrect result.
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GuidanceGuidance to help manufacturers of medical devices classify their devices correctly.
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GuidanceGuidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.
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PageInformation on when software is classified as an in-vitro medical device and how it is regulated.
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Decision treeUse this decision tool to help you determine if your product is a medical device.
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PageDefinitions of terms and links to other information about the regulation of IVDs.
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PageIntroductory material on in vitro diagnostic (IVD) medical devices
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PageInformation about Medical Device Production Systems (MDPS) for prospective manufacturers and sponsors.
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GuidanceGuidance to assist sponsors with the reclassification of surgical mesh devices.
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PageLinks to information on laboratory tests, software and AI based medical devices, personal protective equipment (PPE) and implantable medical devices.
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PageAdvice about systems that are medical devices for sponsors and manufacturers.
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GuidanceGuidance for sponsors and manufacturers about medical device definitions and requirements for system or procedure packs.
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GuidanceGuidance 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.
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GuidanceGuidance on when consumer software products that encourage behavioural change to improve general health or wellness may be excluded from our regulations.
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GuidanceGuidance on when software that makes calculations may be excluded from our regulatory requirements.
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GuidanceGuidance on when software used for clinical workflow management may be excluded from our regulatory requirements.
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GuidanceGuidance on when software that enables communications to support the delivery of health services may be excluded from our regulatory requirements.
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GuidanceGuidance on when consumer software products like apps or websites intended to support users' mental health are excluded from our regulatory requirements.
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GuidanceSoftware or a combination of software and hardware that is an electronic health record (EHR) may be excluded from our regulatory requirements.
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GuidanceGuidance on when consumer software products that promote general health or wellness may be excluded from our regulatory requirements.
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GuidanceGuidance on when software used for the administration or management of health processes or facilities may be excluded from our regulatory requirements.
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GuidanceGuidance on when software products for consumers to self-manage an existing disease or health condition may be excluded from our regulatory requirements.
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GuidanceGuidance on when software products with the sole purpose of storing or transmitting patient images may be excluded from our regulatory requirements.
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GuidanceGuidance about when certain types of laboratory information management systems (LIMS) and laboratory information systems (LIS) may be excluded from our regulatory requirements.
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GuidanceGuidance on when software that is middleware intended to connect or interface applications may be excluded from our regulatory requirements.
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GuidanceGuidance on when software used as a patient reported outcome measures (PROMs) questionnaire or patient survey may be excluded from our regulation.
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GuidanceGuidance about when certain types of population-based analytics software may be excluded from our regulatory requirements.
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GuidanceGuidance on when software that provides alerts to health professionals in relation to patient care may be excluded from our regulation.
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Decision treeUse this decision tree to work out the classification of the medical device you want to sell or supply in Australia.
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PageMedical devices, including IVD medical devices, are included in the Australian Register of Therapeutic Goods (ARTG) as a 'kind of medical device'.
Ingredients and scheduling
Get information about ingredient approvals and scheduling requirements.
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GuidanceGuidance for the requirements applicable to medical devices containing poisons.
Legislation, Acts and Orders
Review the laws and legal orders that regulate therapeutic goods.
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PageFind information about legislation, acts and regulations, legislative instruments and other legislative information.
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PageA list of medical device notices and standards orders.
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LegislationThe Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018 establishes the endotoxin limits for medical devices to minimise risks associated with endotoxin contaminants and residues.
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LegislationThe Therapeutic Goods Act 1989 provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.
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LegislationThis Instrument makes various amendments to the Therapeutic Goods Advertising Code.
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LegislationThis Specification facilitates the public release of specified therapeutic goods information relating to breast implants.
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LegislationThe Therapeutic Goods (Charges) Act 1989 regulates the fees associated with the registration and listing of therapeutic goods in Australia.
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LegislationThis instrument specifies classes of therapeutic goods for the purpose of section 23A of the Therapeutic Goods Act 1989.
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LegislationThis Order clarifies whether specified goods or classes of goods are therapeutic goods according to the terms of the definition of 'therapeutic goods' in the Therapeutic Goods Act 1989.
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LegislationThis Determination specifies goods that are excluded from regulation for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis Specification facilitates the public release of specified therapeutic goods information relating to exemptions that do or do not apply under the Annual Charges Exemption Scheme.
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LegislationThis Specification facilitates the release of specified therapeutic goods information, relating to in-house in vitro diagnostic (IVD) medical devices, to the National Association of Testing Authorities (NATA).
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LegislationThis Specification facilitates the release of specified therapeutic goods information held by the TGA in the database known as the Database of Recalls, Product Alerts and Product Corrections (DRAC), relating to market actions involving therapeutic goods.
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LegislationThe Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Amendment Order 2024 establishes quality and safety requirements for therapeutic vaping devices in Australia.
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LegislationThe Therapeutic Goods (Medical Devices) Regulations 2002 set out the requirements for the registration, classification, and conformity assessment of medical devices in Australia.
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LegislationThese Rules specify circumstances in which a health practitioner is authorised to supply specified medical devices which are not included in the Australian Register of Therapeutic Goods (ARTG), under the TGA's Special Access Scheme category C pathway.
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LegislationThe Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020 outlines the specific categories of therapeutic goods that are excluded from the operation of the Therapeutic Goods Act 1989 (Cth).
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LegislationThis Determination specifies the information that must accompany an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis Instrument specifies certain classes of articles that are considered medical devices for the purposes of the Therapeutic Goods Act 1989.
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LegislationThese regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia.
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GuidanceGuidance to help sponsors understand the legislative powers the TGA can use relating to market actions.
Standards and requirements
Understand product obligations for safety, quality and efficacy.
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FormsThis form is for applying to become an Australian Conformity Assessment Body.
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GuidanceAn overview on the application process for manufacturers aiming to obtain a TGA-issued Conformity Assessment certificate.
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GuidanceGuidance for Australian corporations applying to become an Australian Conformity Assessment Body (CAB) for medical devices, including IVDs.
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PageWhen and how we regulate medical devices that are or use artificial intelligence technology.
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PageAustralian corporations can now apply to become an Australian Conformity Assessment Body (Australian CAB)
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FormsTemplates for manufacturers to make Australian Declarations of Conformity for an in vitro diagnostic medical device.
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PageClinical evidence guidelines: medical devices have been finalised and are now available
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GuidanceGuidance applies to self-tests and point-of-care combo test kits.
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GuidanceThis 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.
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User guideHow to successfully complete and submit an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.
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GuidanceGuidance on ARTG and Conformity Assessment requirements for immunohaematology reagents (IHRs).
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GuidanceGuidance on how to interpret Essential Principle 13B and how it applies to your device.
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GuidanceGuidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.
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GuidanceGuidance on the regulation of system or procedure packs and using the special conformity assessment procedure.
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GuidanceGuidance on how medical devices must comply with the Essential Principles.
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PageWhat you need to submit to include medical devices in the ARTG, including IVDs.
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ChecklistsA checklist to help medical device manufacturers demonstrate compliance with the Essential Principles.
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PageWe will recognise the extended transition for the European Union In Vitro Diagnostic Medical Device Regulation (EU IVDR).
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PageOverview and management of the EU European Union Medical Devices Regulation (MDR) transition under the Australian regulatory framework.
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PageWe will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).
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PageHow to apply for inclusion of face masks (including respirators), that are medical devices, in the Australian Register of Therapeutic Goods (ARTG).
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PageSoftware used as a medical device is normally regulated, but some low risk or already overseen software can be excluded or partly exempt.
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PageInformation on the different types of face masks and respirators.
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GuidanceGuidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations.
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PageInformation on the types HIV tests available and guidance for manufacturers and sponsors on clinical performance requirements and risk mitigation strategies for HIV tests supplied in Australia.
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PageThe International Medical Device Regulators Forum (IMDRF) promotes an efficient and effective medical devices sector.
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PageFlowcharts guiding developers and users of software to decide which software and apps are medical devices.
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PageGuidance for sponsors and manufacturers of in vitro diagnostic medical devices (IVDs) for use in Australia.
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PageThis road map presents an overview of the requirements for supplying an IVD for Australian sponsors.
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FormsInformation and forms about applications for TGA Conformity Assessment certificates.
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PageMedical devices include a wide range of products such as bandages, syringes, in vitro diagnostic medical devices, surgical lasers, pacemakers and dialysis equipment.
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PageNew classifications clarify regulation of software-based medical devices.
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PageA medicinal substance in a medical device must meet Australian manufacturing and quality control requirements.
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GuidanceGuidance for manufacturers to help you manage risks and meet regulatory requirements.
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PageUse our online assessment tool and notification form to transition to the new EU MDR, so you can continue supplying medical devices.
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PageMedical devices must comply with the Essential Principles. These set out fundamental safety and performance requirements.
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GuidanceThis guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations.
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GuidanceGuidance on the transitional arrangements and obligations of medical devices with a diagnostic function.
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GuidanceGuidance for sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) on transitional arrangements and obligations.
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GuidanceGuidance to assist sponsors of medical devices that administer medicines or biologicals by inhalation meet their obligations and comply with regulations
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GuidanceGuidance on the transitional arrangements and obligations.
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GuidanceGuidance on the transitional arrangements and obligations of sponsors and manufacturers.
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PageRegulatory information and requirements of nutrigenetic tests supplied in Australia.
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PageUnderstand what software is and isn’t excluded from our regulation.
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PageAll collection swabs are medical devices and must be included in the Australian Register of Therapeutic Goods (ARTG).
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PageThe Australian medical devices legislation creates a system of non-mandatory medical device standards orders (MDSO) and Conformity Assessment standards orders (CASO) that can be used to demonstrate compliance.
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PageStandards and guidelines for medical devices marketed in Australia.
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GuidanceHow the TGA assesses the safety of materials derived from human and other animal species, naturally susceptible to TSE, that are used in the manufacture of therapeutic goods.
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GuidanceGuidance on clinical performance requirements and risk mitigation strategies.
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GuidanceGuidance for manufacturers outlining the procedures for submitting Conformity Assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)
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GuidanceGuidance explaining sponsor requirements for IVD Conformity Assessment through manufacturer agreements and regulatory compliance.
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GuidanceGuidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.
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GuidanceGuidance on when software is classified as an in vitro medical device and how it is regulated.
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GuidanceThis 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.
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GuidanceGuidance on clinical performance and risk mitigation requirements for self‑test IVDs for chlamydia, gonorrhoea and syphilis.
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GuidanceGuidance 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).
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GuidanceGuidance for sponsors and manufacturers about regulatory requirements for exempt therapeutic goods.
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User guideHow to view and respond to notifications related to an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.
Product types