Consultation: Future regulation of assistive technologies

The current exclusion of certain assistive technologies from regulation is increasingly unsuitable due to technological advancements, changing supply models, and growing customer demand. This consultation is required to ensure regulations for fit-for-purpose. We invited feedback from stakeholders on two (2) proposals to improve the regulation of assistive technologies:

1. The removal of the current exclusion
2. Exempt goods from the need to be included in the Australian Register of Therapeutic Goods (ARTG).

We received 25 submissions from a range of stakeholders, including manufacturers, sponsors, healthcare providers from the fields of assistive devices and allied health, hospitals, consumers, regulatory affairs consultants, and state and territory governments.

Proposal 1: Remove current exclusion

1. Stakeholders were asked whether they broadly agreed with the proposal to remove the current exclusion of “household and personal aid, or furniture and utensils”.

• The responses were mixed, the majority were for the removal of the exclusion. Disagreeing respondents consisted of industry representatives and assistive device providers.
• Respondents who agreed with the proposal suggested that TGA should have improved oversight of these products and that it would improve regulation of them. Some stakeholders said the removal may improve quality assurance of the products and ensure reporting of adverse events. Agreeing respondents noted that the growing complexity of the marketplace requires increased regulation.
• Those that disagreed suggested that the removal may lead to over-regulation and risk the incurrence of additional administrative costs and fees. This burden would ultimately fall on the customer. The disagreeing respondents were industry representatives.

2. Stakeholders were asked to list the financial impacts if the current exclusion were to be removed and what timeframe they would need to implement the proposed changes.

• There was a broad concern that the removal of the current exclusion will have a flow-on effect for the customer. Industry representatives suggested that a removal would increase compliance burden, time and money adjusting documentation and obtaining approvals.
• Respondents said that they would like to have a high quality, accessible, available in many languages source of information as guidance through this transition. There was also concern for a disproportionate impact on small business vendors from the respondents.
• There was broad support for a 1–2-year transition period for the proposal to be implemented. There was also suggestion for a phased approach. An institutional representative noted that the transition may take more than 2 years, if the changes were to be complex.

Proposal 2: Exempt goods from the need to be included in the Australian Register of Therapeutic Goods (ARTG)

1. Stakeholders were asked if they agreed with the proposal to exempt some assistive technologies.  

• Respondents suggested that “lower-risk” items to be exempt from ARTG inclusion. Examples provided included non-weight-bearing devices, those not customized to clients’ specifications, and devices commonly used in everyday settings.
• Industry representatives were concerned an exemption would exacerbate compliance burdens and have limited impact on reducing the cost of regulatory compliance. Exemptions – a couple of industry representatives noted – could impede on innovation within the sector and discourage producers from meeting quality standards.

2. Stakeholders were asked about what information regarding assistive technology they would like to be made public and how it should be organised.

• The responses were mixed. Respondents who wanted information about exempt products were from industry, consumer groups and allied health professionals. Stakeholders noted that devices, organisations, NDIS providers, schools and educational settings, hospitals should be on the list. Agreeing respondents also emphasised that the list should be clear and easy to follow to ensure compliance.
• A disagreeing respondent suggested that it may be “over-kill” since the exemption will likely apply to low-risk products.

• Stakeholders also said that information about exemptions should not be made publicly available where there is a risk of breaching privacy or confidentiality.

Boundaries

1. Stakeholders were asked about which boundary product they thought should be medicalised and which that should not.

• Several respondents suggested that boundary products should not be medicalised because it will restrict supply and are used mostly in every-day settings.
• Respondents suggested a risk-based assessment to decide on exemptions and medicalisation of products.

Further feedback

Stakeholders requested increased clarity and details on how these proposals might be implemented. They asked for more details on the specific issues TGA have experienced with regulating exempt medical devices and assistive technologies. Several stakeholders asked that the TGA conduct educational activities and improve website guidance to increase sponsor awareness and compliance with TGA regulatory requirements for assistive technologies.

Submissions, where permission has been granted, will be published soon.

We have reviewed the feedback provided for this consultation paper. Your feedback will inform internal discussions and further consultations with stakeholders. We will inform stakeholders about any further consultations or related policy updates.