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Software exemptions and exclusions
Generally, software products with an intended purpose that meet the definition of a medical device under section 41BD of the Therapeutic Goods Act 1989 will be subject to regulation by us and will need to be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied.
Certain medical devices, including software-based medical devices, may be excluded or exempt from our regulation in circumstances including where:
- alignment with international regulatory frameworks is appropriate
- unnecessary regulatory burden needs to be reduced or removed for devices where:
- there is no significant risk to safety
- suitable oversight is already in place via an alternative regulatory framework.
Products that have been excluded are completely unregulated by the us. See Software-based medical device exclusions for an explanation of the exclusions.
Medical devices that are exempt are still regulated by us but are not subject to all medical device regulatory requirements and are not required to be included in the ARTG. Depending on the conditions of exemption, some regulatory requirements may still apply including:
- advertising requirements
- adverse event reporting obligations
- notification to us that the product is going to be supplied in Australia.