Software-based medical device exclusions

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.