Consultation: Future regulation of assistive technologies

Closes 31 Oct 2024

Opened 22 Jul 2024

Results expected 29 Nov 2024

Feedback expected 31 Jan 2025

Overview

The TGA is seeking feedback on proposed changes to the regulation of assistive technologies.

The TGA is Australia's government authority responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods including medicines, medical devices and biologicals to help Australians stay healthy and safe.

The current provisions in the Therapeutic Goods (Excluded Goods) Determination 2018 list assisitive technologies “household and personal aids, or furniture and utensils, for people with disabilities” as excluded goods, resulting in such products being considered as consumer goods rather than therapeutic goods.

We are seeking your views about bringing assistive technologies within the therapeutic goods regulatory framework. This would be achieved by removing the current exclusion and potentially introducing an exemption for some assistive technologies.

Exempt devices are regulated by the TGA as medical devices, but are not required to undergo a pre-market assessment or be included in the Australian Register of Therapeutic Goods (ARTG) before they are imported, exported or supplied in Australia. Medical devices that are exempt must comply with regulatory requirements including:

Please read the attached consultation paper and privacy information document.

Why your views matter

Over time there have been changes in this area and we want to ensure the appropriate safeguards are in place now and into the future.

The range and complexity of products has increased, we access more supports to live longer in the community and our service delivery, supply and reimbursement models are increasingly consumer led.

Give us your views - read the consultation paper and answer the survey

Audiences

  • Anyone from any background

Interests

  • Hospitals
  • e-Health
  • Health technology
  • Legislation
  • Regulatory policy
  • Home Care
  • Aged Care
  • Chronic disease
  • Mental health
  • Aboriginal and Torres Strait Islander health
  • Preventative health
  • Policy Development