Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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293 result(s) found, displaying 226 to 250
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GuidanceGuidance on preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance on the use of a medical device in a way that is not included in the intended purpose in the Australian Register of Therapeutic Goods (ARTG), and rules for advertising off-label uses.
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GuidanceGuidance on reporting adverse events for sponsors of medical devices.
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GuidanceGuidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
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GuidanceGuidance for new sponsors on how to supply, import, and export disinfectant products.
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GuidanceGuidance for sponsors of certain medical devices who are required to submit annual reports.
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GuidanceGuidance on when software is classified as an in vitro medical device and how it is regulated.
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GuidanceGuidance to assist sponsors and manufacturers of medicinal cannabis products to conform with TGO 100.
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GuidanceFrom 1 March 2024, a sponsor notice must be given by a sponsor of a vaping good to the TGA before the good is imported into, or supplied in, Australia following domestic manufacture.
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GuidanceGuidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.
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GuidanceGuidance on interpretation of software exclusion criteria to understand the boundaries between software that is and is not regulated.
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GuidanceGuidance about regulatory changes for software based medical devices, including software as a medical device (SaMD).
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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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.
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GuidanceGuidance on regulatory requirements for Ahpra registered dental practitioners making and adapting personalised medical devices for patients.
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GuidanceGuidance on the transitional arrangements and obligations.
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GuidanceGuidance on the transitional arrangements and obligations of sponsors and manufacturers.
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GuidanceGuidance for sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) on transitional arrangements and obligations.
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GuidanceGuidance to assist sponsors of medical devices that administer medicines or biologicals by inhalation meet their obligations and comply with regulations
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GuidanceGuidance about how to apply for a permit to export human substances under the Customs (Prohibited Exports) Regulations 1958.
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GuidanceGuidance to assist sponsors and manufacturers when applying for inclusion in the Australian Register of Therapeutic Goods (ARTG) and selecting a GMDN term.
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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.
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GuidanceThis guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a biological
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GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.