If you're planning to bring a disinfectant or sterilant product to the 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 labelling standards.
Depending on the intended purpose, disinfectants and sterilants are either classified as medical devices or ‘other therapeutic goods’.
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 OTG and all products.
General information
Learn about how products are regulated.
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PageUnderstand how disinfectants are regulated and how to supply them.
Definitions and classification
Understand how products are defined and classified.
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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.
Ingredients and scheduling
Get information about ingredient approvals and scheduling requirements.
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GuidanceInformation to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.
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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PageThe Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories.
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LegislationThis Determination excludes specified hand sanitisers from the operation 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 Therapeutic Goods Order constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.
Standards and requirements
Understand product obligations for safety, quality and efficacy.
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PageInformation on the different ways we regulate disinfectants depending on the intended use and label claims.
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PageInformation for new sponsors about the supply of disinfectant products.
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PageList of disinfectants included in the ARTG for use against COVID-19.
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GuidanceGuidance on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104.
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GuidanceGuidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
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GuidanceGuidance on how exempt disinfectants are defined and meeting the regulatory requirements for their manufacture, supply and advertising.
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GuidanceGuidance about how we define and regulate listed disinfectants, including how to submit a product application and the supporting data and other information required.