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Submissions received: Products used for and by people with disabilities

Options for amendment to the Therapeutic Goods (Excluded Goods) Determination 2018

21 July 2020

The TGA thanks respondents who provided a submission in response to the public consultation paper Products used for and by people with disabilities – Options for amendment to the Therapeutic Goods (Excluded Goods) Determination 2018.

This consultation was related to the implementation of the Australian Government Response to the Review of Medicines and Medical Devices Regulation (MMDR), in particular Recommendation 23 that provided for a review of Class I medical devices "with a view to reclassifying products as consumer goods in circumstances where the product poses little or no risk to consumers should it not perform as specified or malfunctions".

A total of nineteen (19) submissions were received.

TGA summary

This consultation invited respondents to provide feedback on two options to replace the existing 'household and personal aids' exclusion in the Therapeutic Goods (Excluded Goods) Determination 2018:

Option 1 a new definition of 'assistive technology' which might either:

  1. apply for assistive technology products, independent of the risk associated with the product (in line with the existing exclusion of aids for people with disabilities); or
  2. limited to only low risk assistive technology products; or

Option 2 a list of specific products to be excluded from the operation of the Therapeutic Goods Act 1989.

There was broad support for providing clearer guidance to stakeholders in the disability sector as to what assistive technology aids would not be considered medical devices and, therefore, not require inclusion on the Australian Register of Therapeutic Goods (ARTG).

Responses were split between favouring Option 1(b) and Option 2, with no submissions favouring Option 1(a). Some stakeholders did note that while they favoured Option 2, it may impose a greater regulatory burden for the TGA in maintaining the list and some stakeholders expressed concern that the list would not be able to keep pace with new/ emerging technologies.

A number of stakeholders expressed the view that, if Option 1(b) was chosen, any amendment would need to be carefully thought out so as not to inadvertently exclude hearing aids and certain accessories for these aids, as well as prosthesis and orthoses from regulation by the TGA. Stakeholders also raised the issue that the vulnerability of users of assistive technology is a significant factor and, therefore, devices which may not pose risks to general consumers may do so for those with a disability. This would need to be considered when looking to exclude goods from regulation by the TGA.

Post-consultation targeted discussions

Following consideration of the submissions, the TGA consulted with targeted stakeholders, including the National Disability Insurance Agency, on possible approaches.

We propose, considering the rationales provided by respondents and our further discussions with targeted stakeholders, Option 1(b) provides both clarity and flexibility to a broader range of relevant stakeholders. To this end, we have drafted, in consultation with the National Disability Insurance Agency and a number of members of the Low Risk Devices Working Group, a proposed definition of 'low risk assistive technology' to replace the current definition of 'household and personal aids, or furniture and utensils, for people with disabilities' in the Therapeutic Goods (Excluded Goods) Determination 2018.

Next steps

Draft guidance material will be prepared to provide clarification about the devices that will be excluded from regulation by the TGA as a result of the regulatory changes and the transitional arrangements. This material will be provided to stakeholders for feedback prior to finalising the Determination and the guidance and undertaking broader communications.

Submissions received

All submissions that gave permission to be published on the TGA website are available below in PDF format.

3 A E G H I M O Q R S

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