Presentation: Future regulation of assistive technologies information session

Speaker Key:

RA              Rachel

RC              Rachel Croome

AS              Amy Soebagyo

00:00:00

 RA             My name is Rachel. I'm from the TGA Learn team within the Regulatory Engagement Branch, and I’d like to start today's webinar with an Acknowledgement of Country. In the spirit of reconciliation, the Department of Health and Aged Care acknowledges the Traditional Custodians of country throughout Australia and their connections to the land, sea, and community. We pay our respect to their Elders past and present and extend our respect to all Aboriginal and Torres Strait Islander people online with us today.

                   Now it's time to get started on the event. Without further ado, I'd like to pass over to our first speaker today, Rachel Croome, who is the Director of the Regulatory Policy Section of the Medical Devices Authorisation Branch at the TGA. Thank you, Rachel, and over to you.

00:00:43

RC              Good morning, everybody, I'm Rachel, I'll be presenting to you today. I just wanted to start with a brief rundown of what today's session will go through. Basically, in the introduction section, we'll give you a little background on how we got here. It will include a brief background on the broader regulatory requirements. But if you actually need more than we give you today, there is a question-and-answer section at the end, but we're also very happy to talk to people offline, and our contact details will be available at the end.

                   Once we've gone through that brief introductory part, we'll work through the two key proposals from our consultation paper, and there's a section on boundary products, a little chat about next steps. There's resources and contact information, and then we can move into our question-and-answer session.

                   Okay, so the TGA regulates the import, export, and supply of therapeutic goods, including medical devices. Medical devices would generally need pre-market approval from the TGA and must be included in the Register of Australian Therapeutic Goods, or known as the ARTG, before they can be legally supplied in Australia, unless they are exempt or otherwise approved by TGA.

                   The sponsors of the device included in the ARTG must hold and be able to provide manufacturer’s evidence to demonstrate that the products are safe and perform as intended. Sponsors of exempt products, and that's one of the issues we're talking, here, about today, should also have this evidence, even though you don't need to apply to put that product onto the ARTG, and it should be available to supply to TGA on request.

00:02:23

                   Throughout the life cycle of medical device, the sponsor needs to provide that information, and possibly, product samples, and continue to meet all the regulatory requirements, including meeting the essential principles, applying appropriate conformity assessment procedures, and complying with advertising requirements.

                   Here we've got a little slide, which provides some examples of the different classifications of assistive technology. As you can see, they actually spread right across the risk profiles. Class 1 is the lowest risk devices. Class 3 are the highest risk. And you can see there are assistive technologies in all those different classes.

                   The standard ISO 9999, which is for assistive products classification, and terminology, the standard is a pretty comprehensive list of all the different sorts of assistive products for use, primarily outside of healthcare settings, but often also used in healthcare settings.

                   It covers a very broad range of devices, from very simple to very sophisticated technologies. Some of the classic items that we actually think of, like mobility aids, like wheelie walkers and wheelchairs, and as you can see, they're in that Class 1 category. And there's aid for daily living, like shower chairs. Some of the equipment is used in the care of people with disabilities, so for example, lifts and hoists, and transfer aides.

00:03:51

                   Some may be at the boundary of being a medical device, communication devices like Braille keyboards, and computerised communication devices. There are also daily living aids, such as those used for household chores, the preparing of food, and eating, and these can vary greatly. For example, in terms of eating equipment, a straw can be vital for somebody who is navigating the world with a disability. But then that's a very different sort of product from enteral feeding equipment, for example.

                   Some devices, while being useful for people with disabilities, we would generally characterise as being for broader purposes. Some of the things that are included in ISO 9999 are testing equipment, such as blood pressure meters, thermometers, and scales. Some of those scales are very assistive in nature, so they might be, for example, scales for use by people on wheelchairs, or who can't stand, so seated scales. But some of them are just the normal scales that we all have, and they may not even be a device.

                   Some are outside of the medical device regulatory framework, even though they're very clearly assistive technology. ISO 9999 includes adapted vehicles and building modifications, like handrails and grab bars, lifts and ramps, automatic or voice-activated lighting and curtains. These are generally not regulated as medical devices, although they are used as assistive technology for people with disabilities, and other people may also choose to use them.

                   All of these can be very useful for people, but being listed in ISO 9999 does not mean that the product is a medical device under our regulatory framework, or even that it should be. The next slide looks a little more at how we regulate these medical devices.

00:05:46

                   All medical devices, whether they are on the ARTG or exempt, need to have appropriate evidence that they're safe and perform as intended. This means that they comply with the essential principles, have appropriate conformity assessment procedures in place, which are basically quality management systems in place. And that those have been applied to the design and production on an ongoing basis.

                   This can look very different in practice, based on the risk classification. We're looking here at Class 1, these processes are all self-certified by the manufacturer, who makes a Declaration of Conformity to affirm that this has been applied.

                   Third-party certification of that is not required, but you do need to still have the manufacturer has evidence of compliance with the essential principles, and that appropriate conformity assessment is in place, and provide this to TGA on request through the sponsor. The sponsor must have a relationship with the manufacturer to be able to get this evidence as required.

                   It's quite difficult to comply with the regulatory requirements if you only have a contract of sale, you'll generally need a relationship with the manufacturer. When we move on to Class 1, sterile measuring, or 2a to 2b, and Class 3, you must either have TGA conformity assessment certification, so independent certification of these processes, or certification, or approval from a comparable overseas regulator.

00:07:08

                   So that can include notified bodies in the EU, the USFDA, Health Canada, Japan, Singapore, and in some cases, MDSAP, which is the Medical Device Single Audit Program.

                   All applications to include a medical device on the ARTG, certify that the additional information from the manufacturer can be obtained, so the relationship with the manufacturer is important if you don't actually hold the information the whole time.

                   A little quick aside. Looking at the regulation of low-risk assistive technologies internationally, the International Alignment of Medical Devices Regulation can be very important, especially for supply in Australia, where we often rely on approvals from comparable overseas regulators. And so, many of the products that we use in Australia are imported. This is less critical, as I was saying, Class 1, because the manufacturers actually self-certify it, rather than needing third-party certification.

                   But here's a few international examples of how low-risk devices, which include a lot of the low-risk assistive technologies, are regulated in those different jurisdictions.

                   We're not aware of any international jurisdictions that have particular arrangements for assistive technologies, like the one that we have here that we're looking at today. But let us know if you're aware of any. They may, for example, be at the member state level in European countries, or they might be states in the USA. If you do have that information, we'd love to hear about it.

00:08:42

                   Okay, so if we can get on to how assistive technologies are actively regulated, given all of this, the Therapeutic Goods Act, Section 41BD defines a medical device, and the alleviate or compensate for injury or disability is a little bit of a take-out from that.

                   Assistive technologies, as we're saying, often meet that definition of medical devices on the basis of that particular part of the definition. But we have an exclusion in Australia for household and personal aids, or furniture and utensils for people with disabilities.

                   Now, this is an exclusion at the moment, which means that they are outside the regulatory framework. They are basically only regulated as consumer products. One of the things we're looking at today is whether we would move them to being exempt, which means they would be regulated, but don't need to be on the ARTG.

                   Why do we have the current exclusion? It's largely historical. The current exclusion text that, household and personal aids text, dates from the 1980s. It predates our current Act, so it came across from the previous system. The time was quite different, in terms of service models for disability and aged care, such as a lot of public and not-for-profit programmes. A lot of care was institutional, rather than community based, and this allowed for the management of risks around a lot of assistive technologies and their re-use through those mechanisms.

00:10:15

                   Household and personal use phrase of existing exclusion is probably a clearer distinction in that previous environment. The key issues with this exclusion, the TGA regulates on the intended purpose as defined by the manufacturer for a product, not on where they're generally use, so not whether they're using a home setting, versus a hospital or aged-care facility setting.

                   Assistive technologies have also become increasingly diverse and sophisticated. The existing exclusion is not limited to low-risk technologies. Although that's been the way that it's mostly been interpreted, it's not what it actually says. And the risk of excluding these devices did used to be mitigated by the supply, via disability and aged-care programmes and care.

                   The shift in more recent years to market supply mechanisms, and we're also having new issues coming up in this context now around second-hand supply and repair. It's out of scope here, but if you have any comments about the way assistive technology is regulated for second-hand supply and repair, we’re also happy if you do include that in your response. We do have a very keen interest in that area, as well.

                   As I was saying, the problem itself is, at the moment, it's quite unclear, the distinction for household and personal, versus general assistive technology is getting quite unclear. As we're saying, it's established in quite a different time.

00:11:49

                   The nature of the disability sector was, generally, not-for-profit, more of a cottage industry. And the aim, when that was put in, was not to suffocate that sector under a regulatory burden, and the risks were managed quite differently, but the environment is now quite different.

                   We've also had changes in the supply and the use of products. The range of products has really increased, and the changes to technology have altered the risk profile for a lot of these products. It was originally intended that exclusion to be for low-risk products, but as we say, it's not stated in that exclusion.

                   The sector is also experiencing some strong growth in investment. There's been a development of a of wide range of new products, and reimbursement for the cost of assistive technologies from both public and private funding sources is also on the rise.

                   The frameworks such as the NDIS are increasingly moving towards client-led care planning in use of funds. And therefore, there's a need for information to be available to inform the choice that people are making. And this means we need better collection of information and data to build that strong evidence base. Not just about the effectiveness of the products, but also about their value for money, in terms of taxpayer allies.

00:12:59

                   Supply models have also, as we said, moved away from traditional structures using health practitioners, and increasingly, they're direct to consumers. With a lot of non-specialist providers entering the market, we've seen assistive technology being sold at Aldi, Kmart, Bunnings, those sorts of things. There's not a lot of wraparound support for helping people select the right technologies.

                   Now, we've also got changes in sectors that are using the assistive technologies. They continue to evolve to meet consumer need and are becoming more complex. People are living in the community for longer as they age, and increasingly rely on these technologies, along with other interventions to support activities of daily living.

                   Consumers using assistive technology are exposed to risks, and the regulatory framework should safeguard them against this in a consistent and proportionate manner. And publicly available information for these kinds of products is needed to facilitate reimbursement.

                   Exclusion of these kinds of products is, we're arguing, no longer appropriate, given the changes in the risk profiles and the reduction and removal of the previous mechanisms for oversight of the supply of these products.

                   We have previously consulted on a number of occasions about assistive technology. We initially were looking at pushing assistive technologies out of the system, more broadly, but we've moved over time, based on the feedback we've received. Basically, the feedback previously received was agreement that high-risk assistive technologies should definitely be regulated as medical devices under normal arrangements.

00:14:35

                   There was discomfort about excluding these products as an approach, so putting them outside TGA regulation, and discomfort about trying to separate out the household and daily living products from those using healthcare settings as a bit of a false difference. We noted that the diversity of items and the trend towards increased complexity has highlighted the greyness of the current boundaries and the current exclusion.

                   We'll get into Proposal 1 from our consultation paper, and that is to remove the current exclusion. Most assistive technologies, and what we think of as assistive technologies, are Class 1, but this is not true of all products. Hearing aids, for example, are a Class 2a, usually, and we have those various testing equipment's, and things, which are at different levels.

                   If we remove items from the current exclusion, anything that's currently excluded, in the absence of making any other changes, would need to go onto the ARTG, and this slide outlines what the implications of that would be for those products.

                   There are a range of different products that actually would possibly move in and out, and the number of ARTG entries that might be required might be relatively small. But we actually don't have a lot of oversight about the products that would move into the system because we don't know what's currently excluded.

00:16:19

                   We're very happy for people to tell us about the products that they think would be affected. Initial indications are that there is a lot of assistive technology that is already on the ARTG, because it's been provided into context that are not household and personal.

                   They might be using healthcare facilities, and things like that, but you might like to have a think about what assistive technologies you've got that you're supplying, that you think are currently excluded. And as I said, if you think that they would meet the definition of a medical device and therefore be captured if we take the exclusion out, then we would really like to hear about those.

                   As you can see, the application fee for putting a Class 1 application in is $600-odd, and it's about $110, $111 now for an annual charge to keep that entry on the on the market. There's also compliance costs related to that, which are for the process of putting in the application and maintaining documents, and those sorts of things, so you need to have to think about what those obligations actually would be.

                   The current exclusion is narrower than assistive technology. Goods are only excluded where they're for household and personal use, and devices intended for supply in healthcare settings, such as hospitals or residential aged care, already should be included in the ARTG. This is both because they don't satisfy the current exclusion criteria, but also there is often pressure to put them onto the ARTG to satisfy procurement requirements in many healthcare settings.

                   We've got some examples, here, of products. The three on this slide are slide sheets, shower chairs, and stools, and non-powered wheelchairs, and they're all likely to be included in the ARTG already, given that they're typically intended for healthcare facilities, among other places, explicitly or implicitly. Just because the place of use is not specified in the product information doesn't mean that we would not assume that they're for use in health care. It would really require that it's quite explicit about them being for household or personal use.

00:18:34

                   Now, the non-powered wheelchairs, here, are on the cusp of that. Where they customised for individuals, these might be considered personal aids for people with a disability.

                   They may also be captured and included in the ARTG as personalised medical devices, which we changed a few years ago. And they may be supplied under a broader non-powered wheelchair entry, even if they are quite personalised, because they come within the concept of kind of device. If you are familiar with the system, you'll know what that means. Otherwise, it might be something to look into.

                   How are your products being regulated, and would removal of the exclusion raise issues for you? We've got another few examples here, as well. Furniture. We already have an issue with furniture without therapeutic use but intended for use in healthcare settings being included in the ARTG.

                   For example, a bedside table, even though it might have been designed for hospital use, will generally not be a medical device, but people want to include them because of that pressure that comes from procurement areas in hospitals.

00:19:37     

                   Utensils is also pretty clear that they're likely not medical devices. The hot and cold packs is an interesting example because they may be included as medical devices, where they are designed and presented as having a therapeutic purpose, such as treatment of injury or pain.

                   But they may be excluded where they're only intended for personal use, or they're not medical devices at all, because they're not presented as being for therapeutic use. For example, if they're presented as being for comfort or warmth, that's not necessarily a therapeutic purpose. They can be in a number of different categories at the moment.

                   In summary, the TGA doesn't have visibility of items that are currently excluded. We'd appreciate feedback on any items which could be impacted by the removal of the exclusion, the current exclusion, so things that do meet the medical device definition and would become subject to ARTG inclusion. As outlined above, inclusion does have associated costs, and this may be prohibitive for some suppliers and for some products. And we would really like to avoid unintended access issues to these products, so your feedback would be very welcome.

                   In terms of this particular proposal, what are the implications? By putting things onto the ARTG, it will increase the amount of information available about these medical devices, which can provide assurance to the consumers and health professionals. That also can flow into the reimbursement space, so the NDIS, homecare packages and residential aged care. Department of Veterans’ Affairs and things like to see things on lists and being on the ARTG would be helpful.

00:21:35

                   As we talked earlier, manufacturer’s evidence is needed to support ARTG inclusion, that is self-certified for low-risk products but is still required. It's much more specific evidence than anything that's required under Consumer Law, which is what these products would be subject to now and would continue afterwards as well. That would still apply.

                   There is more clarity when the products go onto the ARTG. It is definitely not perfect clarity, but we will get there. Now, there are always costs to greater regulation, and we need to get that balance right. But we also need to remember that there are costs associated with less regulation, and these costs all ultimately flow to consumers. The cost of the product actually impacts affordability and access, but there are also risks for consumers, associated with these products when they fail.

                   The consultation paper, itself, has a number of questions, and we're happy for you to respond to any or all of the questions. There is an online survey at the Consultation Hub, but you can also submit a written submission if you would like, and that gets emailed through, as outlined on the consultation page.

00:22:51

                   The questions here, basically, one and two cover whether you agree or disagree with the removal of this exclusion. Three and four are asking for information about the financial implication and supports that you might need if we were to make this change.

                   We assume that the impacts will be largely driven by the application fee and the annual charges, plus the time taken to comply with the regulatory obligations. But are there any other costs that you would actually be incurring? And what would be the scale for your organisation, is it a couple of applications, which is very different than if you need hundreds of applications.

                   Would you need transitional arrangements? Usually we provide time, often several years, to work through applications if a bunch of them are required, and we can potentially have a look at reduced application fees. You may be aware that the TGA is cost recovered, so there are limits to reduced application fees, so no promises, but if we don't ask, we certainly won't get them. If you think that that's necessary, you should definitely tell us about it.

                   We know that the financial implications can be a driver for your responses on the next proposal, as well, so if you've taken that into account in your suggestions here, it would be worth noting that, as well.

                   So that takes us to the second proposal, which is the possibility of introducing assistive technology exemptions. Now, exemptions can be general, or they can be subject to certain conditions being met, and they're outlined in Schedule 4 of the Therapeutic Goods Medical Devices Regulations of 2002.

00:24:29

                   While exempt devices are not required to be included on the ARTG, they're not excluded from regulation, so the current household and personal aids excludes them. This would mean they were in the system, but it does mean that they don't have to put an entry on the ARTG, but they do have to comply with the essential principles. Apply conformity assessment procedures that are appropriate to the product and comply with advertising requirements. And hold the evidence to demonstrate all of that.

                   The TGA maintains a range of regulatory powers with respect to exempt products, including the capacity to undertake post-market reviews, conduct recall activities. and enforcing offence provisions.

                   It's important to understand the difference between exempt and excluded products. Exempt products are exempt from inclusion, but they are still regulated by the TGA. Excluded products are not regulated by the TGA. However, they may be subject to regulation under other systems, such as Australian Competition and Consumer Commission, and under fair trading provisions for state and territory laws, etc.

                   The rationale for an exemption, here. There are a number of reasons why we might exempt goods that need to be included in the ARTG. We might, for example, be relying on the fact that there are other regulatory frameworks in operation. The risk associated with assistive technologies that are based on prescription or clinical advice from healthcare professionals is very different than assistive technologies, which are purchased online, or from a commercial retailer like Aldi or Kmart.

00:26:06 

                   Now, the TGA doesn't regulate based on the manner of supply, but there may be product groups for which this is actually quite relevant. We also might exempt to avoid supply restriction. The $602 application fee for inclusion, and $111 for the annual charge might be prohibitive if you're only supplying a device a few times, or even quite a lot, with very narrow margins. If those are issues, let us know.

                   There may also be a lack of clinical evidence for some products, particularly relevant for low-risk devices, which are supplied more based on a history of use. There's not going to be a lot of clinical evidence for a shower chair, and this is often acceptable for Class 1, but it's definitely not acceptable for higher-risk devices.

                   And we also sometimes provide for exemptions when we're transitioning between different parts of the regulatory system. For example, where things have previously been excluded, bringing them straight into ARTG inclusion may be a big barrier to supply. And also, sometimes it takes time to come into compliance.

                   We might have an exemption for devices that are transitioning into the regulatory system, and we're using that, for example, for some personalised medical devices, and we've got some halfway houses like that at the moment in the vaping space, as well.

                   In considering what any exemptions might be, we need to have a think about a range of factors and consider the appropriateness, is it actually likely to improve accessibility? But these products are medical devices like any other, is the exemption appropriate?

00:27:51

                   The scope, there's not a lot of appetite for, as I said, medium- and high-risk products to be exempt, hearing aids, spinal stimulators, and things, but we could, for example, have quite a broad approach and make all Class 1 assistive technologies exempt.

                   This would give us clarity about where things sat in the regulatory framework. It would allow for high diversity of products, and there would be fewer issues around some of the marginal products, so eating utensils, and furniture, and things like that, because you wouldn't be putting them onto the ARTG anyway. The broad scope would also mean that products that are already on the ARTG would come off the ARTG.

                   Now, in considering quite how we would frame an exemption, lists are the obvious way, but they're actually quite hard to create, and they're very difficult to maintain. We're proposing that we would use ISO 9999 as the basis for any exemption, but we're happy to hear if you've got other sources or lists that you think might be useful. There we go.

                   Now, one of the issues that we think about with the exemptions is the impact into other systems. Reimbursement systems, such as NDIS, and disability programmes, aged care, often rely on TGA regulating. Now, exempt goods are still regulated by us, so it's a different level of regulation, but we can have a think about that.

00:29:20

                   The other thing that we need to have a think about is, we've recently consulted about exempt devices more broadly, and we need to have a think about, if we're thinking about which things to exempt, what add-ons we might actually use, as well. For example, notification processes for exempt devices might provide a reference suppliers can also use to demonstrate compliance with NDIA, and those sorts of agencies. And we might publish that information, for example.

                   There are also proposals around providing information and samples, so have a little think about those, and you might have to look at the other consultation paper on exempt goods more broadly, and the link is there.

                   Just a quick aside about ISO 9999. The definition of a medical device is for a thing such as an instrument, apparatus, appliance, software, implant, reagent. material or other article for diagnosis, prevention, monitoring, prediction, prognosis, treatment, alleviation, or compensation for disease, injury, or disability. And that's a paraphrase, it’s not an actual quote, but it's pretty close.

                   Where things don't meet the medical device definition, they won't be regulated, even if they're in ISO 9999. For example, there are assistive products for nailcare in ISO 9999, nail files, nail brushes, nail scissors and clippers, not generally medical devices.

00:30:50

                   They also have assistive products for haircare, for washing and grooming hair, generally won't be medical devices, but both of these might have some products that do meet the medical device definition. For example, they might be supplying an easy-to-hold version for those with poor fine-motor skills, for example. That presentation may click it into being a medical device.

                   There are, also, in some of those categories, some things which we may or may not want to actually include. For example, there is assistive products for eating and drinking. Most of the items, probably not medical devices, non-tip bowls, and the big-handled forks, and those things. But some may meet the medical device definition, grip adaptors, and things like that. Do we want these to be exempt?

                   And we'd probably note in that category that there is a subcategory, which is for enteral feeding systems, which we probably would not want to exempt. It's quite a complicated thing to look through that ISO 9999 and think about what should be in and out, and what would already be in and out, based on what's a medical device.

                   If we think about what the exemption might look like, we haven't specified in the paper about what the exemptions might be, we want people to tell us about them. But we've provided a couple of examples, here, that we've already started talking about, to give you an idea about the scope.

00:32:19

                   We could exempt all Class 1 assistive technologies, but we would have to tweak that to remove some medical devices from that, that we wouldn't want to cover. For example, stethoscopes are in there. They're much more broadly used than for assistive technology.

                   We could also exempt targeted categories within that ISO standard. We might, for example, focus on things that are just super low risk, so we might take out weight- bearing items and make sure it's focussed on low-technology devices. Or we might think about the boundary products like utensils, and those grooming and eating, and we'd really be happy for people to provide us feedback on what they think should be in and out of the scope of this. And whether, broadly, it should be a broad scope or a narrow scope.

                   The consultation questions for this one, we're generally asking for your opinion, but we really would appreciate it if you would talk about your rationale. We're very keen to understand the whys because it will help us design something that is fit for purpose, and we can also identify some dependencies that we may be currently unaware of. Five and six are about whether or not we should have exemptions. The scope, yes or no.

                   Seven and eight are more about the information that we might then collect, so would we have notification systems and those sorts of things. And then we've got some more questions over the page.

                   Then we get into some of the specifics of those potential add-onscreen, so are we going to publish information if we were to collect it. Would a notification be by sponsor, which for assistive technology, might be quite a broad notification. It might be for a group of companies that are supplying things. They might make one notification and tell us about the range of products that they're supplying. Or it could be by product, which would mean you would have to do lots of notifications if you're supplying lots of different product lines.

00:34:23

                   This notification would only be for the exempt medical devices. Devices that are included in the ARTG already have some public information. And we need, in designing this part, to have balance. We don't want the exemption process to end up to being more onerous than having an ARTG inclusion. And we don't ask for a lot of detailed information about the products that are in that Class 1 category of all the different products that might be there, so we wouldn't want the notification system to be more onerous than that.

                   The last part of these questions are about fees. Notification could, for example, have an associated fee, which will probably operate a little bit like an annual charge, and that would be to pay for post-market activity. At the moment, the cost of post-market activities for all exempt goods are subsidised from the annual charges paid by people with ARTG entries.

                   We would expect the fee, if it was to have one, would be modest, so more akin to the annual charge for a Class 1, which is $110, but possibly even less. But that would be subject to costings. And because we don't know how many products would be in this group, we currently are finding it difficult to do those costings, which is one of the reasons why we'd really like to know what products you think might be affected and the scope of what that might be.

00:35:37

                   The need for a notification fee of some kind would be greater if we were to do a broad exemption as the number of products that would be shifting from the ARTG exclusion to exemption, and we would still need to undertake post-market activities for all those products. Whereas if it was a much narrower exemption, the need for a fee would be much less, because they're much less likely to generate post-market issues.

                   We'll finish up with our last part of the consultation. We note that the TGA regulates medical devices, and so, we consequently have a very medical framing of what that looks like. Even within the proposals, we would expect that there will be continued tension around the boundaries of the products that meet the definition of a medical device and those that fall outside TGA regulation.

                   Compensating for disability is very broad, but there are lots of products which may not trigger it. We would welcome any advice or input on managing these issues and identifying appropriate edges. We could easily justify capturing a lot of products with a broader definition, but it is possible to capture assistive technologies that don't meet the medical device definition under the broader banner of therapeutic goods, as well.

                   Therapeutic goods actually has a definition, which is where people perceive it to be for a therapeutic use, or likely to be taken for a therapeutic use, so we have some products which, potentially, would not meet the medical device definition, but may still be seen to be therapeutic goods. It gets quite confusing.

00:37:14

                   This paper doesn't make any proposals around changing those boundaries, but we would really welcome any feedback that people have on those, and particularly any problems that you've experienced in practice. In this context, we recognise that there's a tension between social and medical approaches to disability, and particularly in the context of medical device regulation. And like I said, we have quite a medical focus, but if you've got any thoughts, and especially suggestions, on this, we'd also really appreciate hearing about those.

                   Here have some contact information for you. We’ve got question-and-answers coming up, but if you have any queries that you would like to pursue with us offline, and that includes if you would like more background on how things are currently regulated, you can email us at devicereforms@health.gov.au.

                   There is also a medical device information team, and their information is included there. They're really useful to talk to you generally about the way the regulatory system actually works. But also, if you call them, and that is Brian and Tammy, they can put you through to myself or Amy, who are on the project team for this project, if you have queries for us.

                   We're very happy to talk to you individually offline if it will help you work through your thoughts and make a submission to us. Because, as we said, we really would like to know a lot of information that we don't actually have.

00:38:48

                   The next steps, the assistive technology consultation, is up on the Consultation Hub, and the link is there. That includes a survey process, but also, there is actually a consultation paper that you can read. As we said, you can also email to the project team via devicereforms. And also, if you're trying to find Amy, or myself, and our full names are on the front slide, you can call this Health switchboard, which the numbers are there. But as I said, if you come through devicereforms or devices@tga, they will put you through.

                   Welcome back, Rachel. When you can come back on, that would be great and introduce and welcome Amy onto your panel. Amy is going to moderate our questions today.

AS              Hello, everybody. My name's Amy Soebagyo, I'm the Assistant Director, with Rachel and the team, here at TGA. Thank you, everyone, for tuning in and listening. We've got a few questions that have popped through our channels here.

                   Rachel, we've got a question about what information is currently on the ARTG about devices? I guess if we are going to have devices or technologies like this on the ARTG, what's already there?

RC              The amount of information we actually capture on the ARTG for medical devices is pretty narrow, and particularly for low-risk devices. These are included as a kind of device, which means that you can have multiple products actually being supplied under a single entry, and we don't actually have a lot of visibility of those individual products.

00:40:32

                   Where it's the same sponsor, the same manufacturer, the same class of device, and it's the same GMDN, which is the Global Device Nomenclature code, they can be provided under a single entry. If those nomenclature codes are quite broad, you can provide quite a lot of products under a single entry, and we have not a lot of visibility. We don't have a great big list. Notifications for any potentially exempt products might actually be a little bit more informative than what we even have on the ARTG at the moment.

                   Now, we do have a project coming through, which is about the unique device identifiers, but that won't apply to Class 1s in the current implementation plan. It doesn't preclude people from putting that information up, but that would provide information about the individual products.

AS             Thank you. Thanks, Rachel. We've got a few coming through now, so I'm going to skip through and pick a few randomly. And if we haven't had a chance to cover everything, we will also come back to the participants of today's session with a response to those.

00:41:47

                   How would the NDIS use this information, either being on the ARTG, as you explained, or via that notification process that we mentioned before?

RC              Where products are currently regulated by the TGA, the National Disability Insurance Scheme, and a number of other government programmes will actually rely on that as an indication of performance and safety for those devices. And it also provides an avenue for dealing with any issues that actually come up in the use, so they can refer those back to us where there are issues emerging, and we can look at whether regulatory action is actually needed.

                   If items were exempt, and we had a lot of assistive technology that were in that category, it would depend on whether and how we implemented any notification. We would, particularly if it was broad, be quite keen to publish the notifications, which might be quite useful to industry, because it also is a public notice of what they're providing.

                   But also, potentially, have a reference number, so that you can demonstrate that you're aware of your regulatory obligations to funders like NDIA. At the moment, they'll often ask for the ARTG number for things, they might, for example, ask for that notification number instead.

                   We are talking to these other reimbursement-type organisations and programmes, and they are quite keen for there to be a fair bit of transparency in the system, because they're also keen for consumers to have a better understanding of what products are also available, because there's a lot of consumer choice now in those programmes.

00:43:30

AS              Thanks, Rachel. We have a question, here, around, do we have people with lived experience of disability on our team and in our section? And how are we engaging, I guess, to make sure that we've got a good consumer voice in in our work here?

RC              We, unfortunately, do not have anybody with lived experience of disability beyond the very basic things. We've got a few people around who have some disabilities, but it's not necessarily front and centre. Amy is, in fact, an occupational therapist by training, so that is helpful. But that's one of the reasons why we're very keen to engage with the sector on these things.

                   And also, we do have a consumer working group, and things like that, but we've also been talking to the commission, and they've been quite... For example, the issue around the boundaries and the social, versus medicalisation of disability was an issue that they actually raised with us. But we're also keen to continue talking with various people, so if you would be happy to participate in those sorts of things with us.

                   We also anticipate that off the back of this consultation, we will probably come up with proposals that we will also then need quite specific proposals, which we’ll need to work through with various stakeholders. And that would include people with lived experience of disability, and we’ll probably have targeted processes for that, to actually try and engage those people.

00:45:07

                   Again, if you are interested and willing to help, and we realise it's actually quite a big imposition on people, as well, to constantly have to advocate, but we would really appreciate any assistance you can give us.

AS              Thanks, Rachel. And I guess I'll just jump in to say that I know that some of our cross-government working groups also have representatives with people with lived experience of disability, as well. Yes, there are lots of ways we're trying to engage, but absolutely, wanting to get that information from people out there.

                   Following on from that, do we plan to offer easy-read or, I guess, accessibility, in terms of the presentation and the information that we have on our website?

RC              We certainly should have a look into that. It's not something that the TGA generally does. That doesn't mean, particularly on this topic, that it's not something we shouldn't be doing. We will take that one under advisement and see what we can come up with.

AS              Thanks, Rachel. What about time frames for compliance, with any changes that result following this consultation process?

RC              So that will depend on what the changes actually are. If, for example, we go with a broad exemption, actually, it probably won't take too long for people to come into compliance, because mostly, people will be moving off the register.

00:46:35

                   But one of the things that we would like you to comment on is how long you think that things would actually take. But we would generally, at a minimum, make sure that we do the education with people, and we would have a very educative focus, in terms of the transition. It's about trying to reach the people who are affected and help them understand their obligations and come into compliance, rather than, for example, going out with a big stick and trying to punish people for not doing what they didn't know that they needed to do.

                   But the methods of how we help people with that transition and the amount of time that you think is necessary, we're very happy for people to give us feedback on that because it would be very useful to us to know what you think.

AS              Thanks, Rachel. We've got three minutes left, so I'll quickly whizz through what we have left here. Thank you, everyone, for putting through those questions and comments. And for those happy to help, please do get in touch by any of the means listed in the presentation, there. Here’s two of our key emails, and you can attention it to Rachel and I, and it'll get through to us, so thanks very much.

                   We've got a question, here, around the products in the ISO Standard 9999 that you mentioned, Rachel, also fall under other regulatory environments, how would this work if they are moved to exempt?

00:48:04

RC              Some of those items don't currently get captured as medical devices. For example, building modifications, and things, definitely assistive, but we don't regulate them already. There already is an exclusion to push those out. Other items, as were saying, if they meet the definition of a medical device, we might make them exempt. And so, part of what we're actually doing here is trying to figure out what those would be.

                   But whether they're medical devices or not, and whether they're exempt, or they need ARTG inclusion, if there are other regulatory requirements, they still apply. For example, most assistive technologies, particularly in this low group, are also consumer products, and Australian Consumer Law applies to them.

                   And there might be, for example, electrical equipment can sometimes have state requirements, those sorts of things. All of those regulatory obligations for things that are already inside the camp, even if we're moving them around, they still apply.

AS              Thanks, Rachel. And we'll finish off with a very quick minute on this one, which is, you mentioned the compliance triangle before and the kind of things we might do in that space. What other kinds of post-market activities do we undertake, here, at the TGA?

RC              We do a whole series of surveillance, which actually works, and for exempt products, they're often quite similar. For example, we have adverse event reporting. This is where, particularly where there's serious malfunctions which injure or potentially kill people, or potentially could have, manufacturers and sponsors are required to report those adverse events. But we can also take reporting from anybody in the public. And those are very, very useful for us to identify problems.

00:49:54

                   And there might be problems with particular devices, or batches of devices, but there may also be systemic problems with particular sorts of technologies, and if we don't know that those problems are emerging, we can't do anything about them.

                   We also do recalls of medical devices, so if there are problems, we actually have a recall procedure that we follow. And that recall might be calling things off the shelves, but it might also be providing new product information, which has got new warnings, and things, in it. It's not necessarily that a recall means everything's being pulled off the shelves. It can just be new information and a few things in between.

                   We also look at compliance with the Therapeutic Goods Advertising Code, and it's very important when you're making therapeutic claims about products that you're actually in compliance with that code, whether those things are medical devices or therapeutic goods or not.

                   We also look at continued compliance with conformity assessment procedures. So that's the quality management systems, largely, that manufacturers actually run to design and produce the products, and we have an ongoing surveillance mechanism to look at those for things. We also require ongoing compliance with the essential principles, which are the design and safety requirements for medical devices, and that's how we regulate devices more broadly.

00:51:20

                   Also, if people are not complying, there are civil and criminal penalties for not complying with the ongoing responsibilities, and those are set out in the Act. And we have compliance areas that do investigations into those sorts of things. That might come through reporting from people, it might come from observations that we come up with, as well. There's quite a number of ongoing obligations for medical devices, and these, in much the same way, apply, whether they're exempt or they're on the register.

AS              Thanks, Rachel. Now, I know we're two minutes over, so I can see here that we've got, again, our contact information there. As we've said throughout, please do get in touch. We do want your feedback. The consultation paper is on our website, and the link’s there in the chat, so please do feel free to read that a little bit more in-depth.

                   As Rachel said, you can respond that way through the questions via the website, or you can send through an email. You've got our phone number, as well, if you'd like to get in touch.

00:52:25