If you're planning to bring an ‘other therapeutic good’ to market in Australia, this is your starting point.
You need to understand how we regulate these products and your obligations. This includes:
selecting the correct regulatory pathway
preparing evidence
complying with safety, quality and performance standards.
Being well prepared helps ensures your product meets Australian requirements and avoids delays getting your product to market.
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 other therapeutic goods (OTG). You may also have to meet obligations that apply to all products.
General information
Learn about how products are regulated.
Definitions and classification
Understand how products are defined and classified.
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Decision treeUse this decision tree to work out if the product you want to sell or supply in Australia is a therapeutic good.
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PageTherapeutic goods can comprise a broad range of things, such as bandages, pregnancy testing kits, herbal remedies, tissue grafts and paracetamol.
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 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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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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LegislationThese Rules authorise specified classes of health practitioners to supply specified therapeutic goods in certain circumstances, under the TGA's Special Access Scheme category C pathway.
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LegislationThis Specification facilitates the release of therapeutic goods information relating to the importation or exportation of therapeutic goods that are mercury to specified government bodies, to support Australia’s international obligations under the Minamata Convention on Mercury.
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LegislationThis Therapeutic Goods Order constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.