Australia’s Therapeutics Goods Administration (TGA) is currently at work reforming the regulation of software-based medical devices, with an amendment that introduces significant regulatory carve-outs taking effect this week after being postponed due to the COVID-19 pandemic. In support of the changes found in the amendment, the TGA has published guidance on the regulation of clinical decision support software (CDSS) on its website.
Some clinical decision support software (CDSS) is excluded or exempt from TGA regulation
CDSS, broadly defined in the guidance document as software meant to support or enable clinical practice, has previously been required to be included in the Australian Register of Therapeutic Goods (ARTG) when it is deemed to meet the definition of a medical device, unless otherwise exempt. Under the changes introduced in the new amendment, some CDSS will be excluded or exempt even when it meets the definition of a medical device. Software that is excluded is entirely outside the sphere of TGA regulation; exempt software need not be registered but is still subject to a degree of TGA oversight relating to advertising and adverse events. The TGA must be notified when exempt CDSS medical devices are introduced to the Australian market.
The CDSS guidance document assists sponsors and manufacturers in determining whether a CDSS product meets the definition of a medical device, and if so, whether it fits the criteria for exclusion or exemption from regulation. Numerous examples of different software functions are provided in order to demonstrate the application of exemption criteria. Instructions are then given for how to proceed depending on whether the CDSS product is exempt.
This guidance document has been published as a draft, and the TGA invites stakeholders to provide feedback in order to facilitate any needed revisions.
Notification forms now available on TGA website
The notification form for a CDSS product being introduced to the Australian market that is believed to fit exemption criteria is now available on the TGA website. Another newly available form that may be of interest is the notification form for transition arrangements for software-based medical devices, to be used when a product is being up-classified under the regulatory changes.
Related resources on Australian medical device regulation:
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