If you're planning to supply personal protective equipment (PPE) in Australia, this is your starting point.
PPE like masks, gloves or gowns may be regulated as medical devices if they claim to prevent disease transmission between people, resist bodily fluids, or are used in healthcare. You’ll need to understand classification, prepare evidence, and meet standards.
Start by learning your responsibilities and planning each step to meet Australian requirements and avoid application delays.
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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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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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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PageHow medical devices are classified, including in vitro diagnostics (IVDs).
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GuidanceGuidance to help manufacturers of medical devices classify their devices correctly.
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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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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.
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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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GuidanceGuidance on how medical devices must comply with the Essential Principles.
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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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PageInformation on the different types of face masks and respirators.
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FormsInformation and forms about applications for TGA Conformity Assessment certificates.
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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 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).