If you're planning to bring a personalised 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:
choosing the correct category (adaptable, patient-matched or custom-made)
preparing evidence, and
meeting safety, quality, and performance requirements.
By being well prepared, you can avoid regulatory delays.
Start by learning your responsibilities and planning each stage of your product’s lifecycle.
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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PageSteps to include a medical device (including IVD medical devices) in the Australian Register of Therapeutic Goods (ARTG).
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PageInformation about patient-matched, custom-made, and adaptable medical devices.
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GuidanceGuidance and examples to help you understand the regulatory framework for personalised medical devices.
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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.
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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PageInformation about MDPS for prospective manufacturers and sponsors.
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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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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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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 Determination specifies goods that are excluded from regulation for the purposes of the Therapeutic Goods Act 1989.
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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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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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GuidanceGuidance for manufacturers to help you manage risks and meet regulatory requirements.
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PageMedical devices must comply with the Essential Principles. These set out fundamental safety and performance requirements.