Launch of the Australian UDI regulatory framework and Australian UDI Database

Tracey Duffy

Thank you. And good morning, good afternoon, good evening wherever you are in the world. It's my very great pleasure to have you join us today for this webinar. Webinar number 20, for the Unique Device Identification (UDI) system here in Australia. And today, we are very proud and honoured to be formally launching the UDI Regulatory Framework and the database in Australia.

So I just wanted to reflect a little bit before we start the presentation proper and just reflect on what a journey it has been. We had a very strong team and co-design approach in developing and putting in place the UDI system here in Australia, where we work very closely with our stakeholders.

That's not only medical device manufacturers, representative organisations, consumers, healthcare professionals, both here domestically, but also we had a lot of input from external and international stakeholders. And everyone contributed to the development of the UDI here in Australia, but also the database.

And I'd like to thank everyone who was involved, not only the TGA team, but all the external folks who had a contribution to make, however small or great that was. It's through that contribution and that co-design process that we've been able to develop such a great system here in Australia.

We've learnt throughout our journey that the international experience cannot be underestimated. We've learnt along the way about the things that worked well and learned from the things that didn't work well, to take the best of those aspects and try and incorporate those into our Australian UDI system.

The importance and the value of the UDI is one that we can't really see the benefits of until the UDI starts to take shape and be adopted throughout the whole healthcare system. And we all are in the same situation where we have a focus on patients and patient safety and ensuring that medical devices that are used by patients are the very best that they can be. And we all know there are thousands and thousands of consumers all around the world who rely on the medical devices every day.

So, through the adoption of the UDI, if something does go wrong, or there is an issue with any of those medical devices, we now have a way globally, including in Australia, to be able to identify this quickly and take action, no matter where that medical device might be. But the key is that adoption in the health care system.

And whilst we've spent a lot of time building and developing the UDI system here in Australia, the next step is about encouraging that uptake throughout our healthcare system. Navigating through that process, and also educating consumers about the value of UDI and encouraging them to make note of the UDI in any of their records, so that they can actually be assured that there's a way of tracking and tracing their UDI.

What the future brings is to be seen. But what we do know is that patients are going to be better off with this system, and we appreciate all of the stakeholders, the manufacturers, who will start to submit their data, which they have already. And from this point onwards, we'd like to formally launch the UDI in Australia. And I would like to hand over now to Gary to take us through the rest of the webinar, and I'll see you at the other end. Thank you. And over to you, Gary.

Gary Pascoe

Thank you very much, Tracey, and good morning, good afternoon, good evening to all of you joining us around the world as well. We do have a number of contributors to this conversation. Joining us, we have a number of stakeholders who are very interested in what we're doing. So we are very excited and very eager to start working into the next phase.

As Tracey mentioned, we have formally launched the UDI system here in Australia. So this is really the start of a of a journey now for us to be able to talk about the UDI implementation. How we have that adoption start to take place across both the manufacturer and sponsor domain, but also then within the health care sector.

For those of you who don't know me, I'm Gary Pascoe. So I've been part of the UDI Team for the last 4 and a half to 5 years. Looking at the responsibilities for all aspects of the UDI implementation. And I also just wanted to echo Tracey's comments around the thank you to everybody that's participating in this conversation today. But also over the last 4 and 5 years in relation to us developing a system that we are very proud of. And we are very, very eager to really see the next phase of work within the adoption within healthcare.

We have spent a lot of time and effort looking at the alignment and harmonisation across the globe. And I know there were a number of questions from various stakeholders as pre-webinar questions. So we're looking to hopefully address some of those. But there is a lot to cover, and it has been a 5 year undertaking.

So today, we have a lot to cover as part of that process. So we will be talking, at a high level, really, around the UDI system and the introduction of UDI. We have a number of the team sitting in the background. So when Slido opens up, we very much invite you to raise your questions. So, Carolyn Wilson and Anabela Firman from the UDI Team will actually be in the background. Will endeavour to answer any questions that may come up, that can be answered through the Slido chat.

Alternatively, as she mentioned, we'll have some time at the end of the session to cover that as well. So we're looking to try and answer your questions. If we can't answer all those questions. We have the UDI Support Team ready and waiting, and certainly we’ll provide a number of references and links to them as well. And we strongly encourage you to actually look at the TGA's UDI hub.

There's a considerable amount of material in there, both in terms of how that addresses within sponsors and manufacturers, the technical resources and information to support the adoption of UDI. But also then information for healthcare and the use and adoption of UDI within healthcare. So we really strongly encourage you to have a look at that hub, if you haven't. There's a QR code on the screen, and we'd welcome any feedback and thoughts in relation to that going forward.

The UDI regulations took effect from, it really came in 2 parts. So the first part was the amendments to the Therapeutic Goods Act, which actually took effect in February of 2021. And those introduced the concept of the UDI system into the Therapeutic Goods Regulation of the Act. Connected the UDI to the regulations, which then were introduced and took effect from the 24th of March this year.

Those regulations, really, the changes that introduce UDI have woven UDI into the Essential Principles that apply for the Australian medical device regulatory environment.

And so one of the things you'll hear us talk about in terms of compliance, there are a range of requirements for medical devices to be able to meet the UDI requirements. And once we go through the transition periods that we have in place, the ability to comply with those requirements will be crucial, and obviously will fall under their domain of ensuring compliance with the essential principles.

The regulations also have some information around the implementation timing, and dates, and essentially we’ll cover some of those at a high level today. The implications of UDI are really going to affect medical device and sponsors. And those within the health care system will start to see a range of things that start to change within their medical device space.

The first thing is, obviously, probably the thing that's most apparent and we talk about the most, which is UDI information on the device labels, as well as any packaging. That's likely to introduce changes to the barcoding and simplistic forms of barcoding, and some of the information on the device labels, and have that information recorded in the TGA's database.

A number of you in healthcare may see this information already. So there's a smattering and a peppering of these new device labels already starting to come through, because some other jurisdictions have implemented UDI already. And so those devices from overseas will start to come through.

Patient Implant Cards (PICs) will start to require UDI on the patient implant card to actually allow that traceability and that tracking of that device when a patient has a product implanted. Which will then allow information to go to adverse event reports, as well as any research and any device information that a patient or their particular health professional may undertake.

You'll also start to see with the changes with the recalls reforms, and the market actions work. So there'll be UDIs starting to flow through in terms of recalls, market actions, any adverse event and incident reporting as well. And certainly there's been discussion with hospitals and health care around including UDI, once it's available, as part of that mandatory reporting of adverse events by hospitals and healthcare.

So it does have a far reaching implication for a whole range of aspects within the health care system. And really, to come back to Tracey's point, we do see through these changes then the introduction of UDI will start to allow us to have better information about our devices and track and trace them through all stages of the health care system.

The UDI regulations also introduces the concept of a UDI database, which is effectively a repository of all medical devices that are supplied here in Australia. But the information will be linked to the Australian Register of Therapeutic Goods (ARTG). And so really opens up a whole range of opportunities for the TGA to be able to provide additional information about the medical devices that are being used in Australia.

But also then make it easier for those in health care, medical device sponsors, the manufacturers, and end consumers to be able to link and understand what devices are being supplied and what the state of those are. 

The medical device sponsors and manufacturers will have the ability to submit and maintain the data into the database. And that database is then being built to be able to allow ongoing maintenance and sustainment of that information. Because devices actually retained generally have a very long life.

The UDI database and the data in the database will continue for a long time to ensure that if an implantable product or a product that has a long life in, say, 10 or 20 years’ time. If somebody wants to look up and find out information about that device, it will still be there. So, certainly, the UDI database will provide a growing set of information about medical devices that are used in Australia.

It does open up a range of opportunities for health care professionals and quality registries, as well as other stakeholders within the healthcare system to be able to start accessing additional information. It will tie back to items such as the prescribe list and billing codes and prescribed devices. And certainly allow those analysis of devices and better understanding of those products and their performance and operation as well.

And then, obviously, the key point there is giving patients more opportunity to find out more about the medical devices that are used on them or implanted in them.

The UDI implementation will not all happen at once, and certainly it doesn't cover all devices. So one of the things that you'll see us talk about is the devices that are in scope. Essentially, all those medical devices, so any product that's regulated as a medical device is likely to have a UDI. Those devices that are other therapeutic goods that aren't regulated as medical device, such as exempt products, anything that's a boundary product or not regulated as a medical device won't require UDI information.

And in addition, because the focus of the UDI implementation came from a number of medical device crises that we've had here in Australia, the direction from the government was to actually focus the UDI requirements on those higher risk products. So in relation to medical devices, that's a medical device from Class I supplied sterile, Class IIa, IIb and Class III. So as you'll see there, a medical device that's Class I doesn't require a UDI from a regulatory or mandatory perspective.

And similarly, for in vitro diagnostic (IVD) devices, a Class 1 software IVD, or instrument analyser will be expected to consider or be applying UDI. Class 2, 3 and 4 will obviously then need to apply UDI as well.

Those other classes, while it's not mandatory for them to be UDI compliant. So not mandatory for them to have a UDI on the device label or information supplied to the TGA. We would encourage and welcome the opportunity from some sponsors and manufacturers who have spoken to us to say, can we supply that information and be UDI compliant as well? And certainly the database and the TGA is open to that happening.

Now, obviously, once we start to supply that data, then we'd like to keep that up to date so that consumers and the community can have a more accurate reflection of what's actually happening in the medical device space.

It will not apply to other therapeutic goods. So we have a range of questions that essentially have been asked about will UDI apply to specific circumstances? I won't talk specifically about any of those at this stage. But will say that the rough rule of thumb that I would suggest you use and that we use, is if there's an Australian Register of Therapeutic Goods (ARTG) inclusion for that device, and it's specified as a, as a medical device, then definitely potentially in scope for UDI.

If it's not registered as a medical device, or if there's not an ARTG inclusion for that device, then UDI won't apply. So, particularly exempt products, we've had a number of questions about those. So exempt products won't require UDI.

Then also, secondly, it will take some time for us to actually build this database and build this repository and have that flow through to the healthcare system. Because of the changes, and a lot of the international consultation that we've had is really to ensure that we both harmonise our requirements and our regulations with other regulators. And looking to ensure that we don't compromise or affect the Australian regulatory environment, which we're really pleased that we've been able to do.

But secondly, ensuring that the introduction of Australia's UDI also aligns with some of the other measures that are being undertaken, or similar measures being undertaken in other jurisdictions. And in particularly the European Union, with their implementation of medical device regulations and MDR and IVDR.

And so what we've done is we've built a time scale, which essentially really have the mandatory compliance we're giving taking effect from 1st of July 2026. And that will start with the high risk devices. So Class III and IIb. And from now until that point in time, medical device sponsors and manufacturers can supply the information to the UDI database. It is done voluntarily. It gives you the opportunity to start and trial and get a feel for and get ready for the UDI implementation. And one of the key points that I'll make further on in this presentation.

While that sounds it's a long time away and 12 months for those Class III devices, that time moves very quickly. And as part of the international feedback and experiences that other regulators, as well as medical device sponsors and manufacturers have reflected on, is that the time flows very quickly. And particularly those who are bringing products in from overseas, which is a large number of products, that time moves very quickly.

And so we strongly encourage you to start thinking about that compliance and getting ready for your compliance obligations now. It does take time. And so we’ve provided that period of time, industry said it would need 12 to 15 months’ time, and essentially, the UDI requirements will start to take effect. Over a 4 year period, we’ll essentially introduce the different device classes and roll that into the lower risk products. And then effectively, from 1st of July 2030, the full UDI database will be in place, and we expect all devices to be compliant.

And I'll talk a little bit more about what those dates are in a moment. It is quite a complex and overlaying series of requirements in relation to UDI compliance. So really key factors that have a bearing on when you may be expected to, will be expected to comply. Obviously, the first one is with your medical device or an in-vitro diagnostic device. The class of the device.

So, as I mentioned, we will start with the high risk products first. So 1st of July of 2026 for Class III and IIb. And then progressively from July 2027, July 2028, July 2029, start to roll out the other device classes and IVDs from that point in time.

There is some detail that gets into those compliance time frames as well. So those different staging and phasing of compliance time frames do then roll into things that affect the production of the devices, such as items like direct marking. We understand that for some of the manufacturers, it takes time to have medical devices directly marked. For those devices that are reprocessed and reused and cleaned, there is a direct marketing requirement for those products.

And so we do understand that takes time. So we've actually allowed a little bit more time in relation to the time frames to do that. And so that 4-year period really takes from the 1st of July of 2026 to January 2030, essentially provides that time to be able to do that.

There is a complex, detailed guidance document around the timing and implications for different device types. It has a range of examples and specific information about those device types or different scenarios and circumstances. So there's a link there or the QR code on that page. We'll talk more about those.

We do intend to run some workshops to get into more specific detail about individual device types and timeframes. And also talk with you, if required, around some of the implications of what that means for those organisations that are medical device manufacturers and sponsors that are transitioning from MDD to MDR, or IVDD to IVDR.

And ensuring that we've got some time, because one of the Australian commitments, and when we started on this UDI endeavour was really to ensure that we weren't coming ahead of the European transition and so ensure that those dates then take that into effect. So really, the basis of this is, once the UDI information is ready and the compliance is ready in Europe, then we'll be expecting that to be ready and also compliant in Australia. And then medical device sponsors and manufacturers to meet those requirements.

For those devices that are coming out of US or other jurisdictions that already have UDI compliance in place. Then we'll be looking to have you meet those UDI requirements from those key dates in the time frames.

For those in healthcare who are participating here today, you'll start to see products that may come through. So any existing devices that are in the market today, we won't be expecting them to be relabelled or to have UDI compliance. Because obviously that's a massive undertaking and certainly a massive burden for yourselves and industry.

Any new shipments or batches of those devices after these compliance states will need to be UDI compliant. And then any devices also under the control of the sponsor, within 3 years after those compliance date, we will be expecting for Class III and IIb, for those devices to be relabelled. And so, as I mentioned, there's some detailed information in that guidance document to talk about that. So very happy for you to have a look at those. Suggest you have a look at that. And then very happy to take any questions that may arise from your specific circumstances.

I talked a lot around the international alignment, and there was a lot of effort undertaken, as Tracey mentioned, around ensuring that we align with predominantly the UDI guidance and application guide that was defined by the International Medical Device Regulators Forum (IMDRF). But then ensuring compliance with the EU and US.

We have a number of questions as preliminary to the webinar around what would the implications mean for me as a medical device manufacturer or sponsor. And one of the key things I would say, if you are already supplying those products to the EU and US, we've taken a lot of work to ensure that you will accept the UDI carriers. So, i.e. probably in layperson's terms, the UDI labels and UDI barcodes and identifiers that you're using in Europe or the US. If your manufacturer wishes to have them flow through to Australia, then we will accept those labels.

Obviously, the label has to still continue to meet with the broader regulatory and labelling requirements for Australia, so that needs to still fit within that arrangement. And as also, we do have a requirement ensuring that the UDI is issued by one of the globally recognised Issuing Agencies. So GS1, HIBCC and ICCBBA. Now, the beauty of this is those 3 are also used by the US and the EU, essentially every regulator across the globe.

So essentially, if you are supplying those products, you have a UDI that's been issued by one of those 3 organisations, and you already have labelling. There's a high probability that those products will start to flow through and can easily flow through here into Australia. So the extra effort to introduce those into Australia may be not as large as what you may anticipate.

Where the differences do lie, really starting to get around things like some additional data elements. So the US and EU and Australia have a very common and a very core set of data elements. The US and Australia really have a range of information about the medical device that's consistent that will go into the UDI database.

The Europeans expect some additional information, but at the core, it is essentially the same information. So there's a lot of free flow and transparency or trends, ability to flow information and use the data elements used in other jurisdictions and actually have it flow through to the Australian UDI Database (AusUDID). There are some variations, and particularly the European side of things. So I did want to call out a couple of those.

So those of you who may be familiar with the European regulations, concepts is the same, such as the basic UDI-DI, and the master UDI-DI. We don't adopt those here in Australia, so we won't expect you to follow those through and pass those through into the UDI data. As well as in Europe they have medical device nomenclatures, which are different to what we use in Australia. So there are some differences in there.

In Australia, we also have some specific Australian data elements which we've introduced. And so, when you submit that data, you'll need to ensure that that Australian data is there. In particular the ARTG number. So as part of the ability to link UDI to the Australian Registered Therapeutic Goods, we essentially will be asking you to provide that ARTG number, as well as specific information about the sponsor and the medical device manufacturer as part of that data submission.

And so, largely, there's a lot of overlap and a lot of consistency between those data elements. But there are some Australian unique data elements which you should have.

The data submission is, again, similar. Probably the one major difference is we spent a lot of time with industry talking about is how Australia differs a little bit from the US and Europe. That some other regulators have the same concept, which is in the US and Europe, the manufacturer submits the data to the regulator, the various regulators. And so they own that data.

In Australia, we have the role of the sponsor and the regulations and the medical device. The Therapeutic Goods Act, actually defines the role of the sponsor as being responsible for the data. And so we do have some additional considerations here in Australia around managing, ensuring consistency of medical device data when we have more than one sponsor of that product.

If you are interested in that information and how that works, we do have information in our guidance document, or feel free to contact the support team around that. And if you're interested in submitting the data directly, some manufacturers are talking about substantial data sets that will come through to the TGA. We do provide the capability for direct machine to machine. So your electronic transmission of that data, there are thousands of records we can handle.

We are consistent with the US data structure. It's slightly different in Europe because they've taken a different technology approach. But essentially, really, the core elements will be largely the same.

From a device type perspective. Probably the major differences between the US FDA and the EU is that they actually extend their UDI requirements down to Class I medical devices and Class 1 IVDs. As I mentioned before, here in Australia, it's not mandatory for you to do that. However, if you do have Class I devices that have labelling, or you would like to supply the data for those Class I devices. The TGA is very open to you doing that and ensuring they’ve got consistency.

Certainly the conversations with healthcare and healthcare organisations, particularly their supply and product management lines, they would strongly encourage that. And looking for medical device suppliers to extend their barcoding down to that level, to ensure efficiencies in their stock management and their height and management processes.

But certainly from a regulatory point of view, we were open to you doing that. And if that makes it simpler for a medical device manufacturer or sponsor to have those flow through, that is possible to have that happen. There are some slight variations around specific device types, and particularly the definitions of reusable devices. Probably is the third general headline, is, the Europeans have a much more comprehensive set of requirements and rules or definitions of reusable devices and other types of products. Australia is a bit more of a simplified subset of those. So if you're meeting the European requirements, you generally will be meeting the Australian requirements.

So things like reusable devices and whether direct marketing needs to be applied is one good example. And the definition that the Europeans use for whether you require direct marking on the device or not. And Australia is a more simplified example of that.

Other differences include things like some labelling and barcoding requirements within retail settings and the different retail used, as well as over the counter, and the ability to flag and be specific around retail type products. So there is a slight variation there. Again, I would say, as a general rule, Australia is a subset of those, rather than us having anything that's a major departure from what's happening in those jurisdictions.

And obviously the final bit is the US FDA’s UDI system was fully implemented as at 2018. And so they’re all ready and running. And like I mentioned, if you are supplying products and have the UDI compliance over there, and using certificates and having the applications based under the US FDA's conformity assessment process, then we're open to and would actually require you to supply the UDI information for those devices from the initial start date. And the Australian timetable also then takes into account the MDD and MDR transition.

So for those of you in medical device manufacturers and sponsors, I suspect that a number of you are intimately aware of that. For those who are attending today, and actually in health care and a health care setting, or looking at being a consumer of that UDI data. The essence of that is that the UDI data will actually progressively build over the next 4 years.

And certainly as it's starting to build already, but really, from our perspective, there'll be a whole range of information that will start to evolve over those next 4 years. And so the full set of data will take considerable amount of time. It will line up with the other jurisdictions, and it will build over time.

But once that information is in place, then essentially, from a health care perspective, there's a whole range of opportunities that start to open up. The device information, you will be able to search on brand names, device descriptions, model version numbers, catalogue numbers.

Information about the medical device will actually be much more available and actually allow you to go down to specific models of the medical device. So, specific sizes, specific storage and handling conditions, any critical warnings, sterilisation, storage and handling information. So from a medical perspective, additional information, this information will be augmenting the ARTG. And actually allow you to find the information about the medical device in a much more natural manner, rather than relying on some of the traditional methods that we've had before.

Packaging, we’ll start to see different information about the packaging of a device. So a device will require UDI, and its packaging will also require UDI that allow the traceability of those products through all stages of the supply chain system.

So there'll be a range of capabilities, there are a range of capabilities in the database to track from the highest level of packaging down to the individual device and find out. Which will support your management inventory within the distribution centres, within the warehouse, or even within the various stores across the healthcare organisation.

Other information, medical devices that are actually software will also be required to meet the UDI requirements. How that information is delivered does vary and supports some of the software requirements, as well as the Australian UDI database also allows the capture of patient information, leaflets and instructions for use. So it gives the ability for healthcare, as well as patients, consumers to find out information about the device in a much richer and more direct method.

Because that leads through and is linked to the ARTG, you'll be able to find the information about the approval and the status of that approval for that individual or medical device. Again, as I mentioned, you can look up what that does. It opens up a range of opportunities in relation to looking up information, managing inventory, and tracking the products.

Recording, ultimately looking to and where a lot of our efforts will start to shift to, recording the devices used on the patient implant card, discharge summary. And then ultimately, we'd like to see that flow through to My Health Record for patients to be able to access this information.

And then really, it opens up a whole range of opportunities to streamline and be more effective in relation to market actions, any corrections, any recalls that are undertaken for, by healthcare professionals, patients or medical device industry sponsors and manufacturers.

The TGA will be working with a number of health care organisations, which we’ll be opening ourselves up to talking with hospitals on health care. We have spent a bit of time over the last couple of years working with hospitals to better understand their need, and essentially have built the database to allow that access to information.

But we will be starting to have greater discussion with you around how you can access it, how you may be able to do that through online services. Or through electronic interfaces that will start to support more sophisticated searching and synchronising of that data with your internal systems as well.

For industry, I suppose I've covered a lot of it before, but for medical device sponsors and manufacturers, I suppose the key message here is we really encourage you to start preparing for UDI now.

As I mentioned earlier, it does take a considerable amount of time, and certainly industry representatives and medical device manufacturers who have implemented UDI, both in the US and the EU. So don't underestimate the amount of time required to look at your resources, understand the relationship between yourself and the manufacturer, determine who manages and submits the data. If you’re a sponsor or a manufacturer, identify what rules you put in place.

Each jurisdiction does have some slight variations around some data, so getting consistency and standardisation around those, considerable amount of time. And then obviously establishing your operating procedures. And if you are looking to submit that data to the TGA electronically, to start to submit that data by those dates in terms of the key implementation dates over here.

If you are interested, there is a whole range of capabilities for you to test and trial the provision of that information. So those of you who are thinking about starting down this road, the TGA and the UDI support team is here to help you. And we are very interested in ensuring that we can support your ability to actually commence this.

So some things to think about in relation to getting going, talk to your manufacturer, talk to your regulatory affairs team. The key thing is obviously ensuring that the UDI is issued by a recognised Issuing Agency. It may already be issued for other jurisdictions, Europe and US in particular. We're happy to accept those. Depending on your processes and practices, you may look to have a separate UDI for Australia. But essentially those numbers will need to all come from the same centralised, globally unique Issuing Agencies.

Look at your labelling, look at your product packaging. It may have some implications for the packaging and the way you're packaged, because the labelling does add the additional UDI Carrier. And I know a number of organisations say that's a considerable lead time to actually get ready for that. So it's definitely something you need to start thinking about now.

If you are looking to test and trial your UDI data, the TGA has an environment that will support you through to test and trial. So it is something that you don't have to get this right and from day one. So we will support you to test and trial information, UDI database, and I'll talk about that in a moment. And then obviously, then thinking about the UDI on Patient Implant Cards, adverse event reporting, etc. So what that means for your internal processes and practices will certainly also take time to work through.

Data submission to the database. We really have 4 different methods. 2 online and 2 electronic. If you have a small set of data. So somewhere, maybe one record at a time, a small, up to 10 or so records that you support and maintain, then feel free to submit that online. And that will be through the TGA’s Business Services (TBS). So those sponsors who already have a TBS account, essentially, or building on that TBS account. And using the existing privileges and access that you have as part of your TBS access.

If you have more than 10 or you have a range of records, up to about 200. We do have some capabilities to actually allow that to be done more efficiently and through an Excel spreadsheet. So there's a template that's downloadable from the TGA's UDI hub that you can use to populate the information. Have that loaded back up into the database, and make it easier for you to submit the data in a more efficient manner.

For those of you who have more than 200 records, or actually would like to electronically submit the data, and particularly those manufacturers and sponsors who are part of global organisations. Certainly there's been a lot of discussion with them around providing mechanisms for electronic submissions. So we support 2 methods.

The first one is an electronic data submission, using the same standard as what the US FDA use. HL7 SPL, which is direct submission to the TGA's UDI database through an electronic submission gateway. There is some detailed documentation on the UDI hub in relation to the specifications. We are actually happy to work with your technical teams around how you need to do that. This is very much an IT conversation.

So there's very detailed documentation that's on UDI hub around how you can set yourself up and what the requirements are and the rules around that technical implementation. For those sponsors and manufacturers who are using GS1’s National Product Catalogue (NPC) and are certainly ensuring, it's a great opportunity to ensure consistency with those healthcare organisations that are also using the NPC. We also have been working with GS1 to allow the submission of that UDI data directly into the UDI database through the NPC data stream. So there is definitely an opportunity to do that as well.

If you are looking to use that method, we would suggest you talk to GS1 first and ensure that the NPC is set up for you to be able to do that. And then we'll work with yourselves and GS1 to ensure that that can be done. So there's a range of different opportunities for you to provide data. If you are interested in the different pros and cons or the opportunities. We do have a fact sheet we're about to distribute or that’s accessible on the hub that can provide a bit more information on that.

The other key requirements, there are certainly a lot of questions and conversations, and I won't get into detail now, there's a significant amount. But certainly there are some specific devices that, depending on how they're packaged and really how they're used and how they're packaged, there are some additional UDI requirements that actually may apply.

And particularly, concepts of things like if the devices are packaged together and then use in a single procedure, either as kit procedure pack, or a loan kit. Then there are some requirements around ensuring that devices within the kit or within the pack is able to be identified, as well as the pack and its use itself.

So there's a range of sections within the UDI guidance that cover that. And if you haven't had an opportunity to have a look at that, there's definitely strong advice to have a look at that and get a feel for what those specific requirements may be for your particular device types.

For those of you who manufacture and supply software as a medical device or software embedded medical devices, those devices will also need to be UDI compliant. Provided they're a Class III down to Class Is, or an IVD Class 4 to Class 1 instrument analysers, or software based devices.

There are some slightly different requirements around software in terms of how the UDI information is displayed, for example, software that's packaged and delivered electronically obviously won't have a label. So where the UDI information needs to be displayed and accessible does vary. So there are some specific requirements around that. But that fits in with our broader regulation of software as a medical device or software based devices. Again, worth having a look at the guidance document in relation to that.

And then we do have some relaxed labelling requirements for those devices that are principally sold in retail settings. If the device is intended to be sold in retail. And then it's supplied to those retail organisations, there is a reduced requirement around making some of that information available in a human readable form on the labels, due to ensuring that we can have those products still flow.

And so if you are in that situation, or you are a manufacturer or sponsor for those devices that are intended to be sold in retail and supplied in retail. Again, a Class III to a Class Is, which does cover a significant number of products that are sold in retail, either through the existing retailer channels, Coles, Woolworths, Chemist Warehouse, or any pharmacies. Then we strongly encourage you to have a look at that, because there are some variations within the UDI requirements.

And then custom-made/patient-matched medical devices. Again, depending on how they're regulated and managed, if they are exempt products, then again, doesn't need a UDI requirement. But there's certainly some information that’s worth having a look at the guidance in relation to those as well.

So, in closing, I know I talked a lot about information. There is a lot of information. And the team has worked really hard to pull together all that information and allow different views into that information, depending on whether you're coming as a sponsor, a manufacturer, consumer, or a health care organisation.

We’re very proud of the UDI hub and the comprehensive information in there. It does provide a whole range of links and access to information about the regulations. Provides a description of the various terminology and different references to use rules around the different data elements, what UDI means in Australia, and as well as then the UDI database.

The guidance documents can be accessed there. As well as any technical documentation that's available for medical device manufacturers and sponsors, who may either want to upload the data through an Excel template, or use some of the more sophisticated machine to machine documentation.

We are continuing to work on and evolve that hub and adding additional information in relation to requirements for health care consumers, in particular, to ensure that we can make that relevant. And simplify that from a consumer perspective as much as possible. So expect to see that change. So it's not going to be static. And over the coming months, it will continue to evolve and additional information will be pushed out there. And that will be a primary source of us providing information to the community in relation to UDI changes.

For those who are interested, here's a link to the guidance documentation. As I mentioned, there are 2 guidance documents, one for actually the first one to detail support for complying with the requirements. So that talks about all the different rules, the specific specifications for different device types. And it's a comprehensive document in relation to what that may mean for you. Broad UDI requirements, and then drills into those individual device types.

There's a range of examples and scenarios that we talk through that. So hopefully that will help you understand or apply those particular circumstances. If they don't, you’re very welcome to send us an email to the UDI helpdesk and ensure that we can respond to that. Or if there's significant areas of questions around that area, we're very happy to update the guidance document to ensure those examples cover as well.

And similarly, there's a detailed guidance around the time frames. As I mentioned before, there's a range of overlaying and overlapping factors in relation to when UDI compliance may apply. And so that document talks at depth around what those requirements may be.

And definitely, again, we're interested in your thoughts and feedback around the simplicity, usability of those documents. And if you have any questions in relation to what that means for your specific circumstances, we're very open to you sending an email to the UDI helpdesk.

As I mentioned before, one of the other resources we have, we do have this AusUDID production environment. It is for testing and training by medical device sponsors and manufacturers. It's an environment for you, effectively emulates our production environment. So all the rules associated with what you would see in a production environment are there. It will require you to have a TBS ID. It will require you to ensure that you have ARTG IDs for the specific devices you are testing.

And if you're able to do that, then you can put data in, get familiar with the database, either both through the online channels, as well as any of those electronic submission methods. So feel free to use that environment. Contact the UDI's Support Team, UDI@health.gov.au, and access the environment, and essentially provide an opportunity for yourselves, as manufacturers and sponsors, to trial and test that.

And we did have a number of questions to the pre-webinar registrations around whether that was possible. So certainly want to draw your attention to that pre-production environment. The other thing is, the team and the TGA will be looking to have some UDI launch sessions with sponsors over the back half of this year. So it’ll be later in the year, around September and October.

To help us prepare for that, ensure that we can make them as useful as possible for medical device sponsors, we've created this expression of interest page. We would strongly encourage, and we will send this out to all participants in this webinar as well. We strongly encourage your thoughts and feedback around the types of information you're looking to cover in those workshops, whether you can think that would be valuable. And so please feel free to access this and share that with your colleagues as well.

Tracey Duffy

Hi, everyone. Thanks, Gary, for that excellent presentation. I know there was a lot of information that was covered, which sparked a lot of more detailed questions. I've just been looking at the questions, and there seems to be, I guess, some questions that were more high level, but some more specific questions as well.

Quite a number of the questions are answered in our UDI guidance, and I'm glad that we put the guidance link into our chat for people to have a look at. There was a couple of questions around the differences between the US and the European and Australian requirements. And I did answer those questions that said, we did set these out in one of our consultation papers, and that consultation paper is still on our consultation hub.

But it'd be great if you could just confirm whether our new guidance has those differences included in it, or whether people have to go back to that consultation paper to see where the differences are.

Gary Pascoe

I can probably answer that for you, Tracey. So the new guidance doesn't call that out specifically, but certainly, as we receive the pre-webinar questions for this webinar. It became apparent to us that we really needed to just refresh that, so the team will work on that and actually refresh that information, and make that available on the hub.

So it was definitely a strong message from those participating in the webinar, that they're still looking for that information. So we can do that. And ensure that the information on that consultation paper is still up to date.

Tracey Duffy

Yes, that'd be great. I think people are really interested in the differences between the different requirements. There are a couple of questions around when manufacturers can start submitting or accessing the UDI database. And my understanding was that they can do that now. But grateful for your Confirmation.

Gary Pascoe

Yes, definitely, Tracey. So, yes, they can. Probably, the thing I would say is, there’s ability to submit data online through the portal, through the Excel spreadsheet, and now the direct submission is open and available. But we strongly encourage anybody who wishes to do that, to contact us first. Because there's a range of testing and technical work that needs to be done for us to engage with our technical teams. We are doing that with a number of manufacturers and sponsors now, so it's certainly there and available.

We do have some manufacturers who actually submitted data, so we do have the ability for manufacturers to submit data. The one thing I would say is, if you are a manufacturer and looking to submit data, please ensure that you talk to your sponsor about that first, because obviously, ensuring that responsibility and who does that and ensuring that's in place around your agreements with the sponsor will become critical. Because we don't want to get in the situation where you have different organisations trying to manage the same data.

Tracey Duffy

I'll have one more question, then I'll pass to Carolyn. Can sponsors or manufacturers use the National Product Catalogue to upload UDI data into the UDI database?

Gary Pascoe

Yes, is the short answer. Again, work with GS1 on that. Talk to them first, because they manage the National Product Catalogue. But, absolutely.

Tracey Duffy

Okay. I'll hand over to Carolyn now, who might have some more questions, or Anabela.

Carolyn Wilson

Thanks, Tracey. One here, Gary, about combination products containing medical devices, but regulated as a medicine. Would the device labels still require a UDI?

Gary Pascoe

No, essentially, if it's regulated as a medicine, so if it's not regulated as a medical device, won't need to meet UDI requirements, even if it has a device in that as part of that product. The flip side will apply, though, if a combination product is regulated as a medical device and includes a medicine, then there'll need to be a UDI for that medical device component. But there won't need to be a UDI for the medicine in that combination product.

Carolyn Wilson

Thank you. When you’re looking at time, we have tried to answer as many of these questions as we can in the background. So, perhaps if you wanted to wrap up today, and we'll get something out by the end of today that answers most of the themes of the questions. To you, Gary.

Gary Pascoe

Thanks, Carolyn. And I just wanted to just close by saying, thank you again to everybody who has participated in us getting to this point. There is a lot of information we talked about. It is a complex field, and we have had a lot of important contributions from an enormous range of stakeholders, other regulators, medical device manufacturers and sponsors, health care and consumer groups. So it is something that we are really proud of.

We certainly, from our ability to ensure alignment globally where we can, has been something that we are really excited about. And the next phases for UDI, really, definitely something that we're super excited about. We would like you to continue to engage with this.

So if you have those questions and things pop to mind, please feel free to go to the hub, go to the guidance document, contact the support team on UDI@health.gov.au, and we’re looking forward to working and engaging with you, and making this a success. And seeing then the next wave of UDI in healthcare and having it flow through to those key components. We would love to be part of that. And the journey is only starting.