Consultation on Draft Guidance: Assistive Technologies and the Therapeutic Goods (Excluded Goods) Determination 2021

Overview

We have extended the timeframe for submissions to this consultation. We will commence analysing submissions from 22 October 2021. However some stakeholders have requested more time to submit their comments, so the capacity to make submissions will remain open until Friday 5 November 2021. We welcome any feedback stakeholders can provide on this issue.

Stakeholders can also provide feedback by email to LowRiskDevices@health.gov.au 

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The Therapeutic Goods (Excluded Goods) Determination 2018 provides that “household and personal aids, or furniture and utensils, for people with disabilities” are excluded goods, and so regulated as consumer products rather than therapeutic goods. 

This exclusion of aids for people with disabilities is under review, and this consultation provides an exposure draft of the proposed amendment, and related guidance for applicants, for review and comment by stakeholders.

Why your views matter

Previous consultaion was undertaken on this issue. Following consideration of responses to the consultation, and further discussions with a number of stakeholders in the assistive technology sector, a modified version of Option 1B has been progressed.

The intention is to exclude low risk assistive technologies (as outlined in Option 1B) but to modify this to continue to regulate medical devices which, if they malfunction when used as intended, can result in significant injury.  This exposure draft consultation is being undertaken given the shifts from the original option proposed, prior to amending the instrument and implementing this change. 

What happens next

Your feedback will help inform any further refinements to the proposed amendment to Therapeutic Goods (Excluded Goods) Determination 2018. The guidance will also be updated based on feedback and suggestions received, and published at the time the determination is amended.  A communications process will also be implemented to assist stakeholders to transition to the new arrangements.