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Product regulation
Find out about the types of health products that we assess and monitor, as well as how to access products that are not on the Australian Register of Therapeutic Goods.
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Regulations for all products
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information for all products.
Product types
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Biologicals
Biologicals are products made from, or containing, human cells or human tissues. They also include products containing animal cells, tissues or organs.
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Medical devices
Medical devices can be used to diagnose, prevent, treat and monitor medical conditions. Learn more about how we regulate medical devices in Australia
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Medicines
Medicines are substances used to treat, prevent or relieve symptoms of illness and injury, or to change how the body works.
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Other therapeutic goods
Products that are not regulated specifically as medicines, biologicals or medical devices. Other therapeutic goods (OTG) include sterilants and disinfectants, tampons and menstrual cups.
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Unapproved therapeutic goods
Some therapeutic goods can be supplied that are not included in the ARTG. These are called ‘unapproved therapeutic goods’.
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Boundary and combination products
Products that may fall between different regulatory categories or combine elements of medicines, medical devices, and biologicals, requiring specific regulatory determination.