Submission responses
7. Do you broadly agree that the current exclusion for “household and personal aids, or furniture and utensils, for people with disabilities” should be removed?
Please select one item
Radio button:
Unticked
Yes
Radio button:
Ticked
No
8. Why or why not?
Why or why not
Exclusion should stay in place for low-risk items such as modified cutlery, voice amplifiers, Ipad's that are used with AAC applications.
9. What would be the financial impact for you if the TGA removed the current exclusion for “household and personal aids, or furniture and utensils, for people with disabilities”? If possible, please provide a breakdown of the impacts (cost, time, types and estimated numbers of impacted products). This information will be used to quantify the financial impact to all affected stakeholders.
What would be the financial impact for you if the TGA removed the current exclusion for “household and personal aids, or furniture and utensils, for people with disabilities”? If possible, please provide a breakdown of the impacts (cost, time, types and estimated numbers of impacted products). This information will be used to quantify the financial impact to all affected stakeholders.
We use a lot of mainstream devices which are extremely low risk such as voice amplifier, Ipads, universal remote controls, home automation gadgets and these currently not sold as medical devices.
As a prescriber, the onus will be on us to meet the relevant legislative requirements which is not very practical, and we anticipate the costs to be around $100,000 which includes the time to prepare the necessary documentation and TGA costs.
Given the nature of exempt requirements for such low-risk devices, there is a high possibility that the service providers might ignore the requirements.
As a prescriber, the onus will be on us to meet the relevant legislative requirements which is not very practical, and we anticipate the costs to be around $100,000 which includes the time to prepare the necessary documentation and TGA costs.
Given the nature of exempt requirements for such low-risk devices, there is a high possibility that the service providers might ignore the requirements.
10. What period would be needed for your organisation to implement the proposed changes? This information will be used to inform any transitional arrangements.
Please select one item
Radio button:
Unticked
Less than 1 year
Radio button:
Unticked
1 - 2 years
Radio button:
Ticked
More than 2 years
11. Please provide any additional information about transition timeframes
Plese provide any additional information about transition timeframes
Need to put in funding application and gather more resources to meet the change in regulatory requirements
12. Are there assistive technology devices that should be granted an exemption in order to reduce regulatory burden for manufacturers and/or sponsors?
Are there assistive technology devices that should be granted an exemption in order to reduce regulatory burden for manufacturers and/or sponsors?
Yes, devices that are low risk in nature should be exempt as should the mainstream technology that are being used as assistive technology.
Low risk devices can be defined as those which are non-load bearing or upon mechanical or electrical failure do not lead to an adverse event.
Adverse event could be defined as harm to the user, hospital admission, near miss to a potential injury etc.
Examples of low-risk devices include Ipads, voice amplifiers, over bed tables etc
Low risk devices can be defined as those which are non-load bearing or upon mechanical or electrical failure do not lead to an adverse event.
Adverse event could be defined as harm to the user, hospital admission, near miss to a potential injury etc.
Examples of low-risk devices include Ipads, voice amplifiers, over bed tables etc
13. Why or why not? If you are in favour of granting an exemption, please provide the explicit conditions under which an exemption should be granted and explain why an exemption is warranted.
Why or why not? If you are in favour of granting an exemption, please provide the explicit conditions under which an exemption should be granted and explain why an exemption is warranted.
We are in favour of granting exemption for low-risk devices.
Low risk devices can be defined as those which are non-load bearing or upon mechanical or electrical failure do not lead to an adverse event.
Adverse event could be defined as harm to the user, hospital admission, near miss to a potential injury etc.
Examples of low-risk devices include Ipads, voice amplifiers, over bed tables etc
Low risk devices can be defined as those which are non-load bearing or upon mechanical or electrical failure do not lead to an adverse event.
Adverse event could be defined as harm to the user, hospital admission, near miss to a potential injury etc.
Examples of low-risk devices include Ipads, voice amplifiers, over bed tables etc
14. Do you agree that information about exempt assistive technology devices should be collected?
Please select one item
Radio button:
Unticked
Yes
Radio button:
Ticked
No
15. Why or why not? If there are reimbursement programs or schemes that could use information about exempt assistive technology devices, please indicate here the names of those programs/schemes and the department/body/agency/entity administering them.
Why or why not? If there are reimbursement programs or schemes that could use information about exempt assistive technology devices, please indicate here the names of those programs/schemes and the department/body/agency/entity administering them.
Given we are suggesting exemption for only low risk devices, we feel collecting information about exempt assistive technology devices is an overkill.
16. Do you agree that information about exempt assistive technology devices should be made public through a register?
Please select one item
Radio button:
Unticked
Yes
Radio button:
Ticked
No
17. Why or why not?
Why or why not?
We feel that collecting information about exempt assistive technology devices is not required, so answering the question about publishing the information is irrelevant
18. If a registry of exempt assistive technology devices is established, should information be arranged by kind of assistive technology device or by manufacturer/provider/sponsor?
Please select one item
Radio button:
Ticked
Assistive technology device
Radio button:
Unticked
Manufacturer/provider/sponsor
19. Why or why not?
Why or why not?
Easier for people to search a type of product rather a company
20. Do you agree that cost recovery measures should be introduced to recover TGA expenditure associated with the regulation of assistive technology devices?
Please select one item
Radio button:
Unticked
Yes
Radio button:
Ticked
No
21. Why or why not?
Why or why not?
Charging fees for exemption and excluded goods is not appropriate as manufactures and sponsors who provide these devices do not use any of TGA's resources apart from already existing templates on TGA's website.
22. Do you have feedback or comments, both generally or for specific products, on assistive technologies which are appropriate for medical device regulation, and those ‘boundary’ products which should not be medicalised as therapeutic goods?
Do you have feedback or comments, both generally or for specific products, on assistive technologies which are appropriate for medical device regulation, and those ‘boundary’ products which should not be medicalised as therapeutic goods?
Any assistive technology which is load bearing or upon mechanical or electrical failure leads to an adverse event should be appropriate for medical device regulation
23. Please provide any additional comments. Thank you for your input.
Please provide any additional comments
A clear list/guide of assistive technology devices that are excluded and exempt could be made available so it is easier for the industry to work out what regulatory requirements apply to their device.
We made a submission on a previous consultation where we provided a list on what devices should be excluded or exempt and we believe this best way to address the issues this to avoid any misinterpretation or confusion
We made a submission on a previous consultation where we provided a list on what devices should be excluded or exempt and we believe this best way to address the issues this to avoid any misinterpretation or confusion