Official version of legislation
The Federal Register of Legislation is the authorised Australian Government website for Commonwealth legislation. It contains the full text and details of the life cycle of individual laws.
Guidance referring to this legislation
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GuidanceGuidance on when software used for the administration or management of health processes or facilities may be excluded from our regulatory requirements.
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GuidanceGuidance on when consumer software products like apps or websites intended to support users' mental health are excluded from our regulatory requirements.
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GuidanceGuidance on when software used as a patient reported outcome measures (PROMs) questionnaire or patient survey may be excluded from our regulation.
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GuidanceGuidance on when consumer software products that encourage behavioural change to improve general health or wellness may be excluded from our regulations.
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GuidanceGuidance on when software products for consumers to self-manage an existing disease or health condition may be excluded from our regulatory requirements.
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GuidanceGuidance on when software that provides alerts to health professionals in relation to patient care may be excluded from our regulation.
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GuidanceGuidance about when certain types of laboratory information management systems (LIMS) and laboratory information systems (LIS) may be excluded from our regulatory requirements.
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GuidanceGuidance about when certain types of population-based analytics software may be excluded from our regulatory requirements.
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GuidanceGuidance on when software that makes calculations may be excluded from our regulatory requirements.
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GuidanceGuidance on when software that is middleware intended to connect or interface applications may be excluded from our regulatory requirements.
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GuidanceSoftware or a combination of software and hardware that is an electronic health record (EHR) may be excluded from our regulatory requirements.
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GuidanceGuidance on when software used for clinical workflow management may be excluded from our regulatory requirements.
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GuidanceGuidance on when software products with the sole purpose of storing or transmitting patient images may be excluded from our regulatory requirements.
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GuidanceGuidance on when consumer software products that promote general health or wellness may be excluded from our regulatory requirements.
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GuidanceGuidance on when software that enables communications to support the delivery of health services may be excluded from our regulatory requirements.
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GuidanceGuidance to help sponsors understand the potential overlap between certain foods, medicines, devices and cosmetics.
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GuidanceGuidance about how Clinical Decision Support System (CDSS) software is regulated. Find out when this software is exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance to help sponsors determine if their therapeutic goods are medicines, biologicals, or medical devices.
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GuidanceThis guidance describes the requirements for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia.
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GuidanceGuidance for manufacturers and sponsors of personalised medical devices, including health professionals. Learn what we mean by ‘specified articles’ and the difference between exempt vs excluded products.
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GuidanceInformation to help sponsors and manufacturers decide if antiviral‑claim products need ARTG entry to be imported or supplied in Australia.
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GuidanceThis guidance will assist you in determining if a product is a cosmetic or a therapeutic good and how to comply with Australian regulatory requirements and advertising rules for therapeutic goods.
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GuidanceGuidance to help work out if your autologous HCT product is excluded from our regulation.
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GuidanceGuidance to determine the level of regulation of PRP, PRF or conditioned serum products for therapeutic use.
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GuidanceThis guidance helps providers of digital mental health services or products to understand their regulatory obligations.
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GuidanceGuidance to help you understand which therapeutic goods will be regulated as a biological.
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GuidanceGuidance to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.
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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 the transitional arrangements and obligations.
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