Consultation: Future regulation of assistive technologies

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:

• ensuring the devices meet all relevant Essential Principles, including supplying the devices with adequate labelling and instructions for use
• ensuring advertising complies with the advertising requirements
• reporting adverse events

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.

What happens next

Thank you for sharing your views. TGA will carefully read and consider them. We will also follow up with other key stakeholders to get their views. We will print a summary of the sumbisions here.

This information will help us determine the best way to regulate assistive technologies. We will make changes to our legislation and guidence material if needed. We will print any decisions here, update our website and communicate changes widely.