Project checkpoint on what we know and what you can do to get involved

Good morning and thank you very much to all of you for joining with us today. My name is Nishie from the Therapeutic Goods Administration (TGA) Learn Team at TGA, and I would like start today’s webinar off with an acknowledgement to country.

We acknowledge the Ngunnawal People as traditional custodians of the Australian Capital Territory (ACT) and recognise any other people or families with connection to the lands of the ACT and region. We wish to acknowledge and respect their continuing culture and the contribution they make to the life of this city and this region.

Now, without further ado, I will hand over this session to our presenter today, Gary Pascoe. Over to you, Gary.

Gary Pascoe

Thank you, Nishie. Thank you very much. And thank you, everybody, for joining us today. This is the 18th webinar of the TGA’s Unique Device Identification (UDI) project, and we’re really looking to use this opportunity to use it as a bit of a snapshot and a milestone checkpoint to where the project is at and where we’re likely to go.

I know we had a number of questions prior to the webinar, which will fit nicely into where we’re going, what’s happening, and what’s the process. As well as then, some confirmation around particular decisions that have been made around the UDI policy, or proposed policy, direction.

We thought we’d use this opportunity as a bit of a checkpoint, give you an update on that, and then also, call for some support or interest from those sponsors who would be interested in participating, or anybody else who may be interested in more understanding of UDI, to reach out and contact us.

Today, you’ll hear from me, I'm the UDI project lead for the TGA. Many of you would have met me or worked with me in the past. You’ll also hear from Jasmin Hyatt. Jasmin is the manager of our UDI Support Team, so you’ll hear through the course of the presentation to use the UDI@health.gov.au mailbox, and essentially, Jasmin and her team provide support around that. Jasmin will talk to you about a number of aspects around how you can get involved.

We really wanted to focus this session. Really try and split today’s session up into two parts. The first one is, it’s really got the first three elements, which is give you an update on what we know so far, where we have landed. Some of the things that we are considering, in terms of the finalisation of the recommendations or information that the government will then start to look at to consider and make recommendations or advice to us around the implementation of UDI.

So that, really, then, what we’re looking to do over the next six months, so give you an update over the coming months, around our plan, and timeframes, etc. And then have Jasmin talk to you a bit about how we can continue to get your involvement and seek your involvement.

Because it is really important for us to continue to have that collaborative working arrangements with a lot of stakeholders, and with sponsors, and others within the healthcare industry. To be able to get feedback and ensure that the UDI implementation is going to be as straightforward and seamless as possible.

And then, at the end of the session, we have some frequently asked questions. We have a number of questions, so we’ll aim to keep a large proportion of time available for your questions. So, as Nishie had mentioned, if you do have questions you would like to have covered through the course of this session, and they don't get addressed by me or Jasmin as we’re speaking, feel free to put that in the Slido. Jasmin will facilitate a question-and-answer session, as well, so that we can ensure that we can cover as many questions we have left, as possible.

Just moving on to what we do know so far. Essentially, where we have landed with the medical devices and the scope of UDI here, in Australia. A number of you may have seen this and may have heard some of this material through some of the sponsor workshops that we ran in June. But really, as a group, wanted to give everybody an update on what those key elements are. So, certainly, we have pretty well landed, and certainly, have the Minister provided guidance to us in April around the scope of the UDI here in Australia. We’re looking to, actually, include the UDI requirements within the Essential Principles within the medical device regulations, here, in Australia.

And then looking to, maybe there's other elements that we need to include within the regulations and ensure around the submission of that. Excuse me, submission of data into the UDI Database. But certainly, the scope of the devices UDI is likely to apply to, and what we’re expecting to apply to all medical devices, Class III, Class IIa, IIb, and Class I Supplied Sterile (Class Is) devices. UDI we’ll be looking for, and we’ll be calling for all those devices supplied in Australia to meet that classification.

And for in vitro diagnostic devices (IVD), It will be Class 4, Class 3, Class 2. And then, Class 1 devices that are categorised as instrument analysers or software products within the IVD space. So, we have some clarity around that, and obviously then, looking at those devices that fit within those classifications is looking for where we’ll... Where UDI requirements will apply. But those devices that aren't required to be on the Australia Register of Therapeutic Goods (ARTG), they will be exempt. They won't require a UDI to be supplied. Now, our sponsors can supply the UDI onto those devices, whether they exempt or whether they don't fit within that, classifications that I've just listed before.

So, sponsors are entitled, or okay to supply that, so the TGA won't be limiting your provision of the information to the TGA or to including a UDI compliant on your devices. But essentially, it’ll be mandatory for those device classes that I've just listed. We’ve also settled on some positions around the Issuing Agencies. I know we have some questions from participants around will we be able to use UDI’s device identifiers that are used in Europe or the United States (US), and certainly, the answer is yes.

We will be finalising, we have officially... Announcing that issuing agencies from a GS1 Australia, or GS1, HIBCC, the Health Industry Business Communications Council, they will be the second Issuing Agency. And then, the International Blood Products Issuing Agency ICCBBA that's being used by other jurisdictions. Australia will settle on those three Issuing Agencies as our Issuing Agencies for UDI devices, here, in Australia.

The aim for that is to ensure that we have some flowing of products from Europe or US, and that those manufacturers or sponsors who are getting devices from those jurisdictions to look to have those UDI-Dis (UDI Device Identifier), or the labels that are using those jurisdictions simply flow into the Australia market, as well. And really looking to encourage that to happen.

If you are interested in information about the Issuing Agencies, we encourage you to start talking to either us at the UDI helpdesk or make contact with those Issuing Agencies that you may have a relationship with. Talk to them about those devices.

We will support, again, devices coming into Australia with UDI-DIs that have been issued for other jurisdictions. And for those organisations who are manufacturing, here, in Australia, and supplying the products, here, in Australia, then we would encourage you to start talking to one of those organisations around how you can use their systems to be able to allocate you a UDI-DI for your Australian-supplied devices.

For those manufacturers in Australia, or Australian-based manufacturers who are supplying to other jurisdictions, those devices will not be required to carry a UDI by the TGA.

However, we note that if you are exporting to one of the other jurisdictions, there's a very high likelihood that those jurisdictions, Europe and US in particular, will require your devices to carry that. But that's, obviously, for you to determine from a regulatory perspective around what that's required. But certainly, devices that are manufactured in Australia and supplied in Australia will also be looking to carry a UDI-DI.

The final element is that we have settled on a number of data supplier methods. As many of you probably know, as part of the UDI system that we’re implementing, the requirement will be to have labels on your devices and all higher levels of packaging for those devices that are UDI compliant.

As I mentioned earlier that we’ll be supporting those devices, or those labels that are used in other jurisdictions, provided they're compliant with the broader Australian regulatory requirements to be able to take those labels, or the carriers barcodes, etc., that are used in other jurisdictions.

We also, then, have a requirement, the sponsors of those devices that fit within that category will be required to supply the data for those devices to the Australia UDI Database (AusUDID). We’ve created four methods for sponsors to be able to do that, through online, an online system through the Australian UDI Database, that you can enter those records one at a time.

You could, also using the online system, upload a spreadsheet of entries within the UDI database. At the moment, it currently allows for 100 records. We have worked with some sponsors requesting us to increase the number, and we’re working with them to get a feel for what the optimal number is.

Maximum, at the moment, is about 400 or 500 records. But ensuring that it doesn't create any usability issues or systems issues, but we are looking to allow a single spreadsheet to have 100-plus records that, then, can be uploaded into the UDI Database.         

The third method is, then, electronic data submission through the Machine-to-Machine (M2M) method, which is the HL7 SPL format that's used in the US FDA (Food and Drug Administration). We’re in the process, and we’ll talk a little bit later about what we’re doing in that regard.

And then, the fourth one is, then, using the National Product Catalogue (NPC), which is maintained and managed through GS1 Australia. So, those sponsors or organisations who are using GS1, to submit data through the National Product Catalogue. You have the option to use, excuse me, that as a method for submitting data into the UDI Database, as well, and that will be both for creating and amending records, as required.

So, essentially, we have settled on that method, and we’re in the process of finalising all of the material, and we’re also allowing sponsors to test and get themselves ready.

And so, finally, as part of that, data supply methods, we have defined the UDI Data Dictionary and all the required data elements. There is some work that we’re doing around, I’ll talk in a moment, some of the questions around what data elements are optional or mandatory. Essentially, the full set of data elements known, and currently, in the version of the Data Dictionary.

So, we’ll be quite confident that we have a full set of all the materials required, and really, what we’re doing next is then to take that information and start to finalise the regulatory requirements for doing that.

As part of that process for finalising the regulatory requirements, we do have those six areas that we have had some feedback from sponsors, or we are looking into as part of the finalisation process. These six areas, I’ll talk through in a moment.

But really, elements have come back through our consultation engagement with sponsors over the last couple of months since we had some workshops with sponsors in June. And then, finalising key elements around what those decisions are, and then putting that to sponsors before we’re providing advice or providing input into the government’s consideration of the final UDI policy.

So, those key elements are really around the first one, which is the timing of the UDI implementation. One of the key areas that sponsors have provided feedback to is the timing of the UDI implementation in Australia, and how it may fall within the window of implementation of UDI in Europe, in particular. With Europe and the timeframes that Europe is setting, are currently setting, around the implementation of UDI.

It creates a window, where Europeans are expecting sponsors to... Oh, sorry, manufacturers to submit data to the European database, or EUDAMED (European Database on Medical Devices), between quarter two 2024, and then quarter two 2026. And sponsors have highlighted some concerns around the timing and the types of data that Australia may be calling for at the same time.

We actually have looked at a number of options and provided some considerations around how we could deal with that, in relation to minimising the impact on sponsors and the data submission. And also, finding a balance with getting the UDI requirements in place. So, we’re actually finalising that considerations and we’ll be releasing that to sponsors in the coming weeks to then get their feedback.

The second point, which is then clarifying the UDI requirements retail-only devices. One of the questions we had, or number of questions we had, through sponsors, around the unique characteristics of UDI devices that are sold, then, explicitly for retail. And whether some of the requirements for the full UDI to be on the device would be required.

We’ve gone back, referred to some of the processes that are being done internationally, as well as the international medical device regulators guidance, and actually, formulating a view around what are those requirements for UDI for retail-only devices. And again, we’ll be issuing that as part of the material that we’ll be submitting, will send out to the sponsors in coming weeks.

And certainly, have some consultation with retail organisations, as well, to understand the impact and implications of that on them, as well. We’ve had good feedback, and just collating all of that together.

The third point is, then, amending the implementation timeframes. So, those of you who may have participated in our workshops may recall that we were grouping the implementation requirements for in vitro diagnostic (IVD) devices Class 1... Sorry, Class 4, Class 3, and Class 2 together. And then, 12 months later, looking to have the data submitted and the mandatory compliance for Class 1 in vitro diagnostics to follow.

Feedback from the sponsors at the time were saying that the volume of Class 2 devices, and the large number of Class 2 devices occurring at the same time as Class 4 and Class 3 was going to create a large impact on sponsors, in terms of getting their data ready and being able to ensure their devices are compliant.

So, we’re actually separating that timeframe now, and grouping Class 4 and Class 3 together, and then having Class 2 and Class 1 come together as part of our timing and our proposed phasing that we’ll be releasing. We have looked at that advice and agree that our analysis has identified there's quite a volume of devices if we were going to group Class 4, 3, and 2 IVDs together.

The fourth point is key considerations, and one that we’ve had lengthy consultation and consideration over the last few weeks, which is around the rules for managing changes to UDI data.

In Australia, we have a unique situation, which is it is quite different to other global jurisdictions with the implementation of UDI-DI. And that is the presence of the sponsors. And in Australia, the sponsor is the entity, as you know, responsible for the supply of the device, and anything associated with the correct compliance within the Australian medical device regulations. Which is great.

However, in other jurisdictions, it’s the manufacturer who submits the UDI data, and so obviously, the relationship between the sponsors and the manufacturer is important to ensure that we have the correct data from the manufacturer, and then presented by the sponsors.

But then it gets more complicated when we start to have a single device, which may have multiple sponsors here in Australia. And then, also, what’s the approach for managing those changes.

We’ve shaped a proposition, and we’ve shaped how that could work. And again, looking to socialise that with sponsors through the RegTech forum, to ensure that we have got that right and that proposition will work. So that's, certainly, an area that has required quite a bit of consideration, and I wanted to thank everybody who has provided your input into that already.

The fifth element is, as many of you may know, and have seen through some of the UDI material that's been published to date, the Australia requirements are looking to not require UDI for surgical loan kits (SLKs), or system or procedure packs (SOPPs). **Please see disclaimer.

We, certainly, will require UDI on those devices that sit with or are individually packaged, or provided within the surgical loan kitchen, or the system of procedure pack, and that’ll be required. But for the actual kit, itself, we won't be looking for the supply of the UDI.
However, the key question that is coming saying how do we identify that, how do sponsors, and certainly, those in health care identify those devices? And what materials will be used to identify those devices in those kits, so it’s easy at point of care to be able to then understand those?

So, there's some work we’re doing around just providing guidance and getting information, and then, really starting to be able to provide guidance to sponsors and manufacturers around how that could be worked. How that could work. And essentially, not so much a regulatory point of view, but certainly, looking at what guidance we prepare to ensure that we can give some clarity around that.

And the last point is, certainly, some considerations, a little bit of work we’ve done. Certainly, we had some representation from sponsors in other countries. Because as I mentioned earlier, we were, certainly, looking to support labels and labelling from jurisdictions in Europe and US, and then, be able to allow that to flow through.

So, we had representation from sponsors, who were importing products from other jurisdictions, and particularly, Japan, and looking to get guidance around whether that would be something that we could support.

We’ve had some consultation with the Japanese (regulator), as well as looked at, and spoken to sponsors who are actually representing or importing products from those jurisdictions, and looking at giving us a way forward, in terms of how we represent that.

But at this stage, it’s looking like most of those jurisdictions are aligning with the European or the US markets, and there's no specific requirements or anything unique that we need to consider for accepting labelling. So, those of other countries.

So, again, that will all be wrapped up and put out, and released as part of some material that the TGA team and the UDI team will be sharing with our RegTech forum in the coming weeks.

So that's, really, where we know what we’ve done and where we’re going. From a next plan perspective, or what we’re likely to do in the coming months, I really wanted to share this with you to give you a bit of an outline what our timeframe’s looking... As many of you are probably thinking, and certainly, some questions that were recently asked, with all of these activities happening, our goal of having the UDI regulations in place by the end of 2023 is really starting to be under threat.

And so, what we’ve done is we’ve mapped that out looking from the timeframe. So, really, finalising these consultations, as well as the workload that the regulatory drafting team... And certainly, there's a number of government initiatives that are in place that are happening, in relation to changes for government regulations just outside of the health and the TGA space. But also, within other areas within government, all come to the same regulatory drafting team.

Their guidance to us is there's a significant amount of workload. And so, until the second quarter of this year, they won't be in a position to finalise regulatory drafting.

To give you some clarity, what we’re looking to do is provide some of these high-level milestones and dates. Over the coming weeks, as I mentioned, we will be looking to finalise that consultation on those areas that I've just spoken to, and providing some information to sponsors, and getting your feedback.

That will then be feed into the finalisation and the preparation of the regulatory drafting, and the pack of materials that will go to our regulatory team, that will then start to finalise the regulatory drafting.

That will, obviously, have to be taken to government, and the government will provide their guidance and direction on where they would like the UDI rules and UDI implementation to land. And so that will happen in quarter 4 2023, so the back end of this year. We’re really, then, looking to aim to have the finalisation of the regulations in the first quarter of 2024.

At that point in time, looking once the regulations finalised, we really have the ability to tick our final hurdle, and jump our final hurdle, in relation to the regulations, in effect, the UDI Database ready, and ready to go, and having sponsors who are also being brought along as part of that process. So, we’re aiming to have voluntary compliance take effect in the second quarter of 2024.

Now, the timeframes, in terms of mandatory compliance and what happens after that, we will be issuing, as part of the broader consultation on those remaining policy areas, but certainly, that’s where we’re looking to aim to have the UDI take effect, from quarter two 2024.

However, we’re not still standing still while we’re finalising all that. And certainly, if I move back to the left-hand side, we do have quite a number of activities with sponsors and other interested stakeholders participating in feedback on the UDI Database, or some of these key areas.

And so, we have a Pre-Production version of the UDI Database running today. It has been running for some time, and using that as a process, or using that as a tool to help sponsors provide us with some feedback on the rules, regulations, data rules, etc. That is just going to continue.

We have released, recently, or some time ago now, a version of the UDI Database that will include electronic patient information, so patient information leaflets (PILs). Or there's other supporting documents that can be attached with the UDI Database, and we have called for sponsors input and testing of that.

So, we’re looking to get... Over the next quarter or the remaining weeks, is really, to get sponsors feedback on the implementation of that patient information leaflets. But also, at the same time, we’re currently in the process of testing our National Product Catalogue data submission, and we’ll be calling for interest from sponsors, those of you who are interested in testing, and finalising the machine to machine interface.

As I mentioned, we have the Data Dictionary in the process of being finalised, and we’re pretty comfortable, very comfortable, with the data elements. We’re looking now for, we have implemented an Application Programming Interface (API), the ability for sponsors to electronically submit data to us. And we’re looking for those sponsors who would be interested in starting to consider that as in implementation method.

In addition, over the coming weeks, you will see an update to the UDI Hub on the TGA website. We note that it has gotten a little bit out of date, and certainly, not reflecting the number of the things that I've spoken to today, so we’re in the process of refreshing that. In the coming weeks, you’ll see an update of the TGA website, or the UDI Hub on the website. We’ll be looking to use that to ensure that we have accurate and more current information as the process is starting to go.

As we are getting closer and closer to finalisation of those key areas, we are getting more and more confident around those particular dates, and it is something that we are now really starting to bring together and coalesce. Around ensuring that the database, the regulations, and all of the information supporting products all come together to ensure that sponsors, or any other stakeholders interested in knowing about UDI have the information that's relevant to them.

In the last quarter of 2022, 24, 23, sorry, as I mentioned, we will be finalising the regulatory drafting, getting the government considerations, and ensuring that we’re clear of what government’s requirements are around UDI implementation. And then, that will reflect into the regulations.

We’ll continue the machine-to-machine and NPC testing. So, between now and Christmas, we are very interested in those sponsors who would be willing to participate in some of that testing, and in growing that number. You will see requests from the UDI Support Team in the coming weeks, around getting involved in that.

In the first quarter of 2024 is, really, we have finalised all the technical materials. We’ll have the database ready and packaged, all the support documentation released, with the view to having sponsors ready, being prepared so that we can go live for Voluntary Compliance in that second quarter of 2024.

So that's where we’re looking, our current deadline, and timeframes. We will continue to work through that. As and if they change, we’ll certainly be notifying this group or others through the TGA website and through other forums. But as I mentioned, it is something that we are subject government direction and government approvals. We’re, certainly, looking more and more around ensuring that these are the dates we’re working pretty closely towards.

Hopefully, that has answered a key number of the questions that you have. I will very gladly take some more questions on anything specific, as we get to the question-and-answer session. But before we do that, I would hand over to Jasmin to have a bit of a talk about what you can do, in terms of involvement.

Jasmin Hyatt   

Great, thanks so much, Gary. We do have a lot of great questions coming through, just so you know, on the Slido app. Just to recap, Gary has covered a lot of this, but I just wanted to recap how you can get involved.

Currently, we are working on the Australian UDI Database (AusUDID) Pre-Production environment, so that's available now, as we speak, for sponsors and manufacturers of medical devices. Those users can test the functionality and the current available data upload methods.

We also have a UDI Technical Working Group (TWG), so the TWG, that's for data providers, so that covers sponsors, manufacturers, and third-party data providers. You can attend if you're one of those three. You can attend the UDI Technical Working Group.

They’re held around twice a month, and cover topics such as grace periods, upload functionality, trigger fields, so when you change to the UDI records might trigger in a new UDI. And other technical aspects of AusUDID. So, if you're interested, if you're a sponsor, manufacturer, or third-party data provider, and you're interested in attending, please send an email to us.

You can also visit the UDI Hub, as Gary mentioned. We currently have webinars, previous consultations, news, and updates on there, and we will be refreshing all of our content and the information over the coming weeks, so keep an eye on the UDI Hub. We’ll, probably, also, send some emails out to our stakeholders, letting you know that that's available, but you can always check in at any time on that.

What can you do as a sponsor or manufacturer to get involved right now? Well, as I've mentioned, you can email us if you want access to AusUDID, if you want to join the Technical Working Group.

If you do want access to the Pre-Production environment of AusUDID, you can test out how it looks and feels and give us some feedback on your experience. Feedback is very important to us and has been throughout this entire process. It helps us make sure that our products are usable, are user-friendly, and that they're doing what they're supposed to do.

Gary mentioned you can also test the PIL’s functionality, so the Patient Information Leaflets, so that's a current feature. We currently have the two out of four data supply methods. So that's, currently, the online, and online bulk methods. I know there's some questions about that in the Q&A, which we’ll address shortly.

National Product Catalogue (NPC), we are finalising that testing, and that about to go live. If you are interested in using the NPC method, you can send method, you can send us an email, and when that's available to you, we can add you to the list to test that functionality. And machine to machine (M2M) will be the last of those four data upload methods.

As Gary also mentioned, if you're a sponsor or manufacturer who’s not yet working with one of our accredited issuing agencies, you might want to start considering which Issuing Agency to utilise. As mentioned, that's GS1, HIBCC, and ICCBBA. And they're the three that TGA will be working with at the moment, to start with.

Feel free, as well, to email us at any time, UDI@health.gov.au, if you have any questions on any of the material we’ve covered so far. And that's it from me on that. Over to you, Gary.           

Gary Pascoe   

Thanks, Jasmin. From a schedule perspective, and our plan for the agenda today, was really, then, to start getting into some of the questions that have been asked to date.

There are a number of questions that we have been asked, so I might touch on those, and answer those, but use that as an opportunity for you to... If there is anything that is top of mind you would like to ask, feel free to use the Slido app to raise it.

Again, if you see a question that you like, feel free to upvote that. Jasmin and I will work through those questions, obviously, from the ones that are most popular, and time permitting, hopefully, we’ll get through them all. If not, we will look to address them.

But certainly, our key four questions, I think we may have covered a lot of this already. The first one was when will the UDI regulatory framework be finalised? As I mentioned, we are looking for that to be completed.

So, regulatory drafting, subject to government approval and government direction on that. But really, to start taking effect from next quarter, and then for the back end of year, more likely, in the quarter one 2024, for the regulations to be finalised, to take effect. And then we’ll notify that for the UDI Voluntary Compliance period to actually commence.

We are, obviously, working through a number of those key questions that I highlighted before, so there is some work that we’re doing and value your input into that. But it is the number of things that we’re looking to finalise is diminishing, and we’re getting quite comfortable with some of the elements we are landing on. Again, subject to taking that to government and having their approval, or their consideration, recommendation on that.

Mandatory Compliance, when will that take effect? Again, as I’ve mentioned, the current plans are to have that Voluntary Compliance period open for some time, and as part of our finalisation of what our timeframes and recommended timeframes for government will be, will be informed.

So, as part of that key considerations and implications of the European UDI rollout, the implementation of UDI within Europe, and the implications of filing data with EUDAMED is something we’ve considered. We’ll provide some more information to the sponsors around that.

How do you get a UDI? I think we’ve covered that. For those who are interested in a new UDI, that if you don't supply goods or import goods from US or Europe, that have met the UDI requirements, then talk to one of those three Issuing Agencies that both Jasmin and I reflected.

As one of the updates to the TGA website and the UDI Hub, we’ll be providing more information about those three Issuing Agencies with part of that update. That information will be on the Hub. And then, the final question, when will the AusUDID Production be released, we’ll continue in our Pre-Production form until the regulations take effect. And per my previous comments, that is looking to be around the second quarter, end of first quarter 2024.

We’ll continue to have the UDI Pre-Production version and the test version of the UDI Database running until that takes live. And so, as it’s finalised, as regulations and our final elements are positioned and finalised, we’ll be updating that Pre-Production version to ensure that it is a mirror of what that final version of Production will be.

If you haven't already registered your interest in the UDI Pre-Production, AusUDID Pre-Production, feel free to contact the support team, and that will give you some visibility and, at least, an understanding of what the capabilities are and how you use the system.

So, thank you, I think that's all. There are a couple of other questions that came through on the pre-webinar, prior to the webinar, is there an update on machine-to-machine?

Machine-to-machine is something that we have finalised. We, actually, are releasing a version, or an update, of the capabilities of the machine-to-machine into our Pre-Production environment at the end of this month. Or actually, by 29th September, we’re looking to have a version of the machine-to-machine capabilities in place.

And then, we’ll open it up to a small group of sponsors and manufacturers looking to use it to ensure that we do some testing with that small group. If you are interested in participating in that, please, let us know at the UDI helpdesk. We will be providing information on not just the data model, the data specifications, HL7 standard, but also, aspects of how to get into the API, how to use the API, and the keys to get access, etc.

That’s very much a technical, very technical, conversation, so feel free to bring your technical teams to be participating in that conversation. But we invite you to register your interest with the support team.

Once we have some testing, and then we’ll open that machine-to-machine interface up to greater numbers, but certainly, we recognise that sponsors have made your investment in machine-to-machine. So, we want to try and get it vetted out as early as possible and ensure that it’s correct before we start. And stable before we start because sponsors spending too much and effort to ensure they can accommodate it.

The second question, what details needs to be included on the labelling to meet Australian requirements? Essentially, that's a number of things associated with that. From a UDI point of view, we will, essentially... There may be some distinctions between different types of devices, but if I make a broad and general statement, coming backwards, there’ll be a requirement for a human-readable form.

So, the UDI-DI, and then the production information, so that’s associated with the full UDI to be both in a human-readable form, as well as machine-readable form on the label.

The particular symbology that we are looking for, the TGA is not mandating or requiring any specific symbology. So, we’re looking for manufacturers and sponsors to be able to determine what’s the right... Whether it’s a barcode, whether it’s a QR code, a data matrix, or some other method, in terms of being able to encode in a machine-readable form the UDI information. We’re relying on manufacturers and sponsors to work out what’s most suitable for their particular market.

There are some requirements. If you are using Radio Frequency Identification (RF ID) tags, to be able to ensure that there's also a human-readable form on the label, itself. But certainly, we’re not really specifying whether you use a particular type of 1D, 2D data matrix code. There will be some more information on the updates to the Hub around that requirement.

Third question, will the United States FDA, European Commission compliant UDIs be accepted in Australia? Yes. Yes, is the short answer. Now, obviously, if you're going to be supplying devices with those UDIs on them, then we will be requiring you to submit that data into the Australian UDI Database, as well. Any devices that are supplied in Australia, that are coming from those jurisdictions, we will need the UDI-DI, or the UDI information, in the database.

When can sponsors test the AusUDID Pre-Production? Now. We’re very open and very interested in getting sponsors’ feedback, both in terms of helping you understand some of the rules and some of the requirements of UDI, but also, on the usability.

We’re very interested in getting your response on usability of the database, is there anything that doesn't make sense or is not intuitive, from your perspective. We would be really welcoming ongoing feedback, from that perspective.

So, if you haven't had access, or haven't been granted access as a sponsor to the UDI Database... And we are limiting access, at the moment, to sponsors to ensure that we have data in, and we can use data, and the data is valid before we start to open it up to other stakeholders. But if you are a sponsor and you are interested, then please, get in touch with the UDI helpdesk, UDI@health.gov.au.
I think that's all of the pre-submitted questions. We might just pause for a moment, I think I’ll hand back to Nishie, and just have a moment just to encourage you to raise your questions on Slido. We’ll spend the next 15, or so, minutes responding to those questions.
Jasmin Hyatt    

All right, Gary, do we want to start to take some questions? We’ve got a lot of questions here today. We will do our best to answer as many as possible. If you feel like you don't get the answer well explained to you, or if there's something else you would like to ask, please, email us, UDI@health.gov.au, and my support team will get back to you as soon as possible.

So, first question, Gary. This one’s been upvoted quite a few times, and you have touched upon it a little. When is the TGA planning to publish UDI regulation and implementation timelines?

Gary Pascoe 

Yes, thanks, Jasmin. It’ll probably be published in two parts. So that’s a broad timeframe that I just outlined and had on this slide. Obviously, we’ll publish as part of this webinar. We’ll look to put that onto the UDI Hub, as well.

However, until we have government advice and direction, in terms of timeframes, and specific timeframes, we won't be able to publish that. If I go back to the previous slide around timeframes, we’re looking for that to take effect... Get to government, have their considerations and their recommendations in the last quarter of this year.

And then, once we have more certainty, and obviously, from the government’s point of view, what they're looking to do, in terms of considerations and timing, then we will publish more definitive timeframes and dates as part of that. We’re working within that broad parameter that I published and talked through before. Once we know more, we can put that in place. But we, certainly, will be looking for providing more clarity as part of the updates to the TGA Hub.

Jasmin Hyatt      

Wonderful, thank you. Next question, can you, please, repeat the device categories that will be mandated to have UDI?
Gary Pascoe   

Sure, I certainly can. And again, it is in an update... So, the update to the UDI Hub will contain this information, as well. Like I mentioned, we are in the process of finalising that, and we’ll have it out. It’s all new information because it is something that we’ve had government direction on, in terms of scope. But to answer your question.

So, medical devices Class III. I’ll take a first step and step back. If the device is required to registered on the Australian Register of Therapeutic Goods (ARTG), and it is a Class III medical device, a Class IIb, Class IIa, or a Class I supplied sterile (Class Is), then as a broad statement, there may be some exceptions and different characteristics in different device types, they’ll be expected and required to have a UDI and meet the UDI requirements.

For in vitro diagnostics, so IVD, Class 4, Class 3, Class 2. And then two collective terms, or two categories under the Class 1, so instrument analyser and software. If you really want to get precise, I think it’s CT, so collective term 943, and collective term 944 will fit within the scope of being required for UDI requirements.
So, again, to reinforce, if it’s a Class I Measuring or a Class I device that's not supplied sterile, it’s not mandatory for you to meet the UDI requirements, but as a manufacturer or a sponsor, if you wish to do that, we certainly will support that happening. Hopefully, that answers the question.

Jasmin Hyatt    

Thanks, Gary. I'm not sure if we can answer this one. GS1 is selling country specific UDIs, isn't this the whole purpose of the UDI to be unique worldwide?

Gary Pascoe  

Yes, I couldn't speak on behalf of GS1, in relation to what defines as a country-specific UDI. If you had some examples, we’re happy to talk to GS1. It’s not just the regulatory requirements around the UDI. UDI, itself, is meant to support the regulatory flow of the device through the healthcare system. So that’s supply chain, point of care, clinical, as well as then, through to all the things associated with patient information and records.

It is quite a complex code. All I can say is there may be other supply chain considerations, but please, take that up with GS1, but certainly, from an Australian point of view, we are supportive of using a UDI-DI for devices supplied in other jurisdictions, sorry, in Europe and US, and we’ll look to support that. But there may be some other rules at GSI but talk to them about that.

Jasmin Hyatt     

Great, thanks, Gary. Next question, this one’s a long one. Including UDI in the Essential Principles makes it difficult for the manufacturer to sign off and on when it is the responsibility of the sponsor to ensure it is loaded in the system. Has the TGA considered this and looked at alternatives? So, this is about

Gary Pascoe     

Yes, it is, and it, certainly, is something we’ve considered. As I mentioned at that start, and I was talking, there are some elements around the Essential Principles that we are looking to have UDI requirements in there.

But where they fit, and how they fit, and the obligations on the manufacturer and sponsor is definitely something that we have been looking at and considering. That will feed into the final recommendations for government and regulatory drafting. I couldn't say where we’re landing at this point in time, but it’s definitely a key factor in our considerations. But thank you.

Jasmin Hyatt    

Thanks, Gary. The next one, I think I can answer, but, Gary, feel free to jump in. We’ve got a request here to publish the draft UDI guidance document and draft AusUDID Data Dictionary on the TGA website.

We are currently, as we’ve mentioned, looking at all of the content on the UDI Hub on the TGA website. Those documents are, certainly, something that we’re looking to include soon, to allow people to be prepared and understand what’s required. Yes, the short answer, we are looking to publish more supporting information as soon as possible.

All right, next question. What is the planned number of maximum uploads of the UDI records included in the Microsoft Excel spreadsheet upload for the bulk upload within AusUDID.

I can answer that one, as well. Sorry, Gary, to steal your thunder.

Gary Pascoe       

No, that's all right.

Jasmin Hyatt  

Well, previously, it was 100 records, but as Gary mentioned earlier, we have tested the functionality for up to 500 records. I'm unsure if that's live yet, but if it’s not, it will be live in the not-too-distant future. So, yes, certainly looking around 500 records.

Gary Pascoe       

Yes, and just to add to that, Jasmin. One of the considerations we’ve got now is with 500 records, it does create performance issues for the sponsor, or the person submitting the data, as well as for us. It’s one of the things that we’re working through, at the moment, to ensure that we don't create technical issues for you because, certainly, things timeout. We’ll be working with a sponsor to be able to say there are implications of that, so we may reduce that number down.

So, it is something we’re finalising, but certainly, until the electronic interfaces are in place, we’ve had sponsors ask us to increase the number, and we’re looking at how far we could take that without creating usability issues, from your perspective. Because unfortunately, using Excel, embedding and using Excel, within that environment does create some challenges from the technical perspective, but it will be more than 100.
 

Jasmin Hyatt   

Great, thanks for clarifying, Gary. How are we doing for time? All right, we’ve got time for some more questions. Next question, can you expand on the point you made about not requiring UDI on procedure packs and systems?
 

Gary Pascoe  

Yes, because this one, there's probably a bit of a broader explanation, if you're okay, I might take that one on notice, and will actually issue a written response to that, just to ensure we cover... There are some permutations and combinations associated with the procedure packs and loan kits, so... And ensure that we give some clarity, I’ll give take that on notice and provide a written update on that particular requirement. *Please see disclaimer.

Jasmin Hyatt   

Great, that one was listed by someone who posted anonymously, so if you are one of those people wanting that information, just email us through at UDI@health.gov.au. We’ll also, as I said, be updating information on Hub as we’re able to release it, so in the future, I'm sure we’ll have more information on that for you.

Next question, how will over the counter (OTC) devices be affected?
Gary Pascoe    

Yes, thanks. So that relates to the comment before, and the considerations around retail-only devices. We have been asked by sponsors to consider what other jurisdictions in Europe and US are doing around the requirements for the full UDI on retail-only devices. And so, we have documented that, done some research, and looked at putting a proposition together to get sponsor feedback.

If we’re talking OTC, meaning it’s over the counter and retails exclusively, then we’ll have that response together. And then, we’re looking to seek the sponsor feedback on that. That will go out to sponsors via the RegTech members. If you are members of RegTech, if you are interested in registering your interest in knowing more about that, then please, email the support team.

Jasmin Hyatt  

So, next question, will (Software in a Medical Device) SIMDs, I'm assuming that Software in a Medical Device, be mandatory, or optional, as this has not been required for US, EU, Saudi, Taiwan, or China?

Gary Pascoe   

Yes. Again, if it fits in with those device classifications that I listed earlier, and regardless as to whether software is a medical device or not, or software in a medical device, then that device will be required to supply a UDI. There are some provisions around how the software is packaged and how it’s reported. So again, there's some information to provide a bit more clarity around that. But software as a medical device, or software in a medical device fit in one of those broad classifications, then it will be required to meet the requirements. 

Jasmin Hyatt     

Great. Wonderful. And just time for a couple more questions. I think we’ve covered this one already, but is TGA planning to accept medical device that comply with UDI requirement according to EU MDR 017/745?
 

Gary Pascoe 

Yes, I’ll take that on notice and respond because there's a bit more finer-grained response to that. There’re things which, for example, European require around, Basic UDI, Master UDI-DI, etc. That won't apply, here, in Australia. So, certainly, where we’re looking for a UDI matches the specifications for Europe, there are some other things that are European requirements, which are unique to Europe, so it won't be something that we’re asking for, here, in Australia. I’ll take that on notice, Jasmin.

Jasmin Hyatt 

No worries. I'm not sure if we can answer this one, but does the UDI need to match the medical device evidence? So, for example, if the device is certified with the EU manufacturer evidence, does this require the EU UDI and the same for US, or doesn't it matter?

Gary Pascoe  

So, at a higher level, and again, this is what’s happening from the EU, in terms of manufacturer’s evidence. But it’s unique to the device and the characteristics of the device, it’s not just the UDI, in terms of device identifier, it’s the characteristics of the device encapsulated in the UDI Database. We’ll, obviously, need to match the characteristics of the device defined on the conformity assessment, or the manufacturer’s evidence that have been supplied by the manufacture. So that's all part of that certification process. I may not have answered that question, I’d love to know more, specifically, about that, but happy to... Send us an email or reach out to the team, and we can make sure that you receive clarity around that. I think we’ve pretty well run out of time, Jasmin, so I'm happy to...

Jasmin Hyatt    Yes, we’ve run out of time. If we haven't answered any of your questions today, please, feel free to email UDI@health.gov.au, my team will respond. We’ll formulate a response and respond to you. Otherwise, we’ll hand back. 

Nishie Hewage   Thank you, everyone, for joining us today. Have a lovely day. Thank you.

Gary Pascoe  Thank you, everybody.