Software that meets the definition of a medical device under Section 41BD of the Therapeutic Goods Act 1989 will be regulated by the TGA unless it has been excluded. Excluded products are listed in the Therapeutic Goods (Excluded Goods) Determination 2018 (the Determination).
These products:
- are not regulated by us, and
- do not need to be included in the Australian Register of Therapeutic Goods (ARTG).
There are currently 15 categories of software products listed in Schedule 1 of the Determination. If your product meets all the conditions of an excluded good described in the Determination, it is not subject to TGA regulation and must not be included in the ARTG. No further action with the TGA is required before you begin supplying it.
If your software does meet the definition of a medical device and is not excluded, it is regulated by the TGA and must be included in the ARTG before it can be marketed, sold or distributed in Australia unless a valid exemption in place.
For more information about exempt software, please review our guidance on Exempt software as a medical device.
Note: Software with multiple functions
Some software products have multiple functions. To qualify for exclusion, every function must meet the exclusion criteria.
There are 15 software exclusions outlined below.
Behavioural change and coaching software
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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.
Calculator software
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GuidanceGuidance on when software that makes calculations may be excluded from our regulatory requirements.
Clinical workflow management software
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GuidanceGuidance on when software used for clinical workflow management may be excluded from our regulatory requirements.
Communications software
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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.
Digital mental health tools (DMHT)
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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.
Electronic health records software
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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.
General health and wellness software
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GuidanceGuidance on when consumer software products that promote general health or wellness may be excluded from our regulatory requirements.
Health alert software systems
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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.
Health facility management software
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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.
Health self-management software
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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.
Image storage and transmission software
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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.
Laboratory information management software (LIMS)
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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.
Middleware
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GuidanceGuidance on when software that is middleware intended to connect or interface applications may be excluded from our regulatory requirements.
Patient survey software
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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.
Population-based analytics software
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GuidanceGuidance about when certain types of population-based analytics software may be excluded from our regulatory requirements.