Consultation on Draft Guidance: Assistive Technologies and the Therapeutic Goods (Excluded Goods) Determination 2021

Closes 8 Oct 2021

Opened 26 Aug 2021

Results expected 29 Oct 2021

Feedback expected 5 Nov 2021

Overview

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. 

Give us your views - assistive technology

Audiences

  • Medical Devices & IVDs

Interests

  • Health technology
  • Regulatory policy
  • Home Care
  • Aged Care
  • Residential Aged Care