If you're planning to supply a software medical device in Australia, including those using artificial intelligence, this is your starting point.
You need to understand how we regulate these products and your obligations at each stage.
This includes:
determining if your product meets the medical device definition
determining if an exclusion or exemption applies
selecting the correct classification
compiling evidence of safety and performance.
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 medical devices and all products.
General information
Learn about how products are regulated.
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PageInformation for software manufacturers when AI is considered a medical device, and how we regulate AI medical devices.
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PageCheck if your product is a medical device and if it needs to be included in the Australian Register of Therapeutic Goods (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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PageInformation about how we regulate medical devices and how to get your medical device approved for use in Australia.
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GuidanceInformation about how Clinical Decision Support System (CDSS) software is regulated, including when they are and are not exempt from inclusion on the 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 interpretation of software exclusion criteria to understand the boundaries between software that is and is not regulated.
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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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GuidanceFind out how TGA regulates software and artificial intelligence (AI) based medical devices.
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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GuidanceGuidance to help manufacturers of medical devices classify their devices correctly.
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PageInformation about our regulatory approach for software based medical devices.
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GuidanceGuidance on interpretation of software exclusion criteria to understand the boundaries between software that is and is not regulated.
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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'.
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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LegislationThis Instrument specifies certain classes of articles that are considered medical devices for the purposes of the Therapeutic Goods Act 1989.
Standards and requirements
Understand product obligations for safety, quality and efficacy.
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PageInformation for software manufacturers when AI is considered a medical device, and how we regulate AI medical devices.
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GuidanceGuidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.
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GuidanceGuidance 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.
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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 how medical devices must comply with the Essential Principles.
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ChecklistsA checklist to help medical device manufacturers demonstrate compliance with the Essential Principles.
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PageInformation about our regulatory approach for software based medical devices.
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PageFlowcharts guiding developers and users of software to decide which software and apps are medical devices.
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FormsInformation and forms about applications for TGA Conformity Assessment certificates.
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PageNew classifications clarify regulation of software-based medical devices.
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GuidanceGuidance on the requirements that specifically apply to active 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 when software is classified as an in vitro medical device and how it is regulated.
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GuidanceGuidance for sponsors and manufacturers about regulatory requirements for exempt therapeutic goods.