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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PageCheck your product is a medical device that needs to be included in the Australian Register of Therapeutic Goods (ARTG).
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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.
Definitions and classification
Understand how products are defined and classified.
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PageUnderstand how medical devices are classified in Australia, including risk-based classifications and how device classification affects regulatory requirements and ARTG inclusion.
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GuidanceGuidance to help manufacturers of medical devices classify their devices correctly.
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Decision treeUse this decision tool to help you determine if your product is a medical device.
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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 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 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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PageMedical devices, including IVD medical devices, are included in the Australian Register of Therapeutic Goods (ARTG) as a 'kind of medical device'.
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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PageFind medical device notices and standards orders under Australian legislation, including regulatory requirements, compliance obligations, and updates affecting medical device supply and use.
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LegislationThis Instrument makes various amendments to the Therapeutic Goods Advertising Code.
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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 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 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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LegislationThis instrument is made under the Therapeutic Goods Act 1989.
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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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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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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.
Standards and requirements
Understand product obligations for safety, quality and efficacy.
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FormsApply for TGA Conformity Assessment body determination with the official application form, including eligibility criteria, assessment scope, fees and documents.
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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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PageAustralian corporations can apply to become an Australian Conformity Assessment Body (CAB), enabling them to assess medical devices against regulatory requirements.
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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 complying with the Essential Principles for medical devices in Australia, including safety and performance requirements, risk management, design, and evidence needed for ARTG inclusion.
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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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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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FormsAccess TGA medical device Conformity Assessment application forms and guidance, including requirements for supporting data and certification.
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PageA medicinal substance in a medical device must meet Australian manufacturing and quality control 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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GuidanceGuidance on the transitional arrangements and obligations of sponsors and manufacturers.
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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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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