Australian UDI update, workshop summary and AusUDID Pre-Production demonstration

Nishie Hewage

Welcome to Unique Device Identification Webinar 17. Today, Gary Pascoe and Bruce Thomson will provide an Australian Unique Device Identification update, a workshop summary, and Australian Unique Device Identification Pre-Production demonstration. I would like to acknowledge the traditional owners and custodians of the lands on which we meet today and pay my respects to Elders, past, present and emerging. I would like to extend that acknowledgment and respect to any Aboriginal and Torres Strait Islander people here today. Now we’ll hear from Gary Pascoe, the Unique Device Identification Project Manager.

Gary Pascoe

 I will give you a bit of an update. It has actually been four months, I looked at, since we had our last Unique Device Identification webinar. And in between that time, there’ve been a lot of activities and quite substantial engagement with the sponsors in particular around the proposed policy direction for the Australian Unique Device Identification.

 And I’d like to give you all an update on where that’s at, talk to you specifically around what came out of some face-to-face workshops and what we found in the participation through face-to-face workshops that we held in Sydney and Melbourne over the June period.

As I mentioned, Bruce will then also give you a demonstration of the Australian Unique Device Identification Database Pre-Production environment. And certainly, for those of you who are interested sponsors, we really welcome your registration or your interest in using that environment and your feedback on how that environment may be refined and changed to suit how you’re operating.

And then at the end of the session, just to build on what Nishie said earlier, we would like to work through, depending on time or to what questions we are able to cover, essentially walk through the questions and answers that you may have asked through the Slido app through the course of the session. So, we’re looking to aim for about 15 minutes or so to be able to cover questions and answers from our timeframe.

So, the Slido app will be opened up partway through the session. So, feel free to raise those questions as we’re going and as things come to mind once it’s open. But also, to reinforce what Nishie said, we’ll use that question-and-answer session to specifically address those questions.

And if there’s any questions that we haven’t been able to answer, I think we will definitely be providing a response to all participants here, as well as other stakeholders we generally engage with, to ensure that we’ve got a common understanding of the responses to the questions, but also ensuring there’s consistency across the group.

So, our Unique Device Identification Support Team will manage those questions and answers and send them out and distribute to those who have participated in the webinar as well as if you’re registered for our updates.

So as I mentioned, we have had a busy number of months, and certainly since I last spoke to you on our Unique Device Identification webinar about four months ago, which is at the point where we acknowledged or we gave notice that the Voluntary Compliance date which we were aiming at to do midpoint of this year, due to a range of challenges with the regulatory drafting as well as finalisation of some of the policy intent, is being moved to the back end of 2023, which is… Essentially, our target was in the last quarter of 2023.

Since that time, there’s been a number of things that have happened, and we’ve had some fantastic engagement with a whole range of sponsors. We’ve actually had some feedback on some of the work we’re doing, and certainly it’s confirmed that we’re looking to be on track for our Voluntary Compliance to commence from December 2023. And with that, we then have the Unique Device Identification regulations take effect.

Now, all that will be subject to finalisation and commitment and approval by the government in terms of their recommendations. And so, essentially, that’s really where the key challenges are for us now, to be able to ensure that the government is briefed and is aware of what the options are for Unique Device Identification implementation and then provide their guidance on how they would like that implemented.

In that meantime, and I’ll talk a bit more about that schedule and timeframe, but since then, however, we’ve actually had a number of things happening. And certainly, the slide in front of you, we can show there’s probably four major activities that have commenced.

So, as I mentioned, we have released the Australian Unique Device Identification Pre-Production environment, which we released in April, the back end of April, early May. So, since the last webinar, that has been made available. And we’ve had a number of sponsors register to use it and provide feedback since it’s been opened up.

We would actually encourage and be very welcoming of any sponsor who was interested in having access to the Pre-Production environment, and then providing us with feedback in terms of usability or any other considerations that may be delivered through the Pre-Production environment. And Bruce, we have a dedicated separate session with Bruce to be able to talk through and demonstrate some of that with you later on today.

So that environment is very much, as we’ve talked about, is a Pre-Production. It is really looking to mirror the Production environment. So that will be progressively incremented changes. Actually, as feedback comes through, we are progressively making updates to the technical solution.

And so, as sponsors, we would like to see you coming back and reusing it, providing feedback, so that we can make sure updates are occurring, but also ensuring that you have our most current and active environment, that you can actually test and look through the Unique Device Identification database.

So that’s been made available to sponsors. As part of that Pre-Production environment, we’ve actually been extending and refining both the online side of the Pre-Production environment, which Bruce will talk you through today, but we’re also adding to, and ensuring that the consistency around some of the data elements and the interfaces with the National Product Catalogue and the machine-to-machine interfaces are actually also being updated to reflect both some finalisations with the data elements, but also ensuring that some of the extended features that had come out of our Sandpit testing have been incorporated into the National Product Catalogue and the machine-to-machine interface.

So, we’re in the process of finalising that now. We are expecting, working with GS1, to have that National Product Catalogue interface and the data exchange for the National Product Catalogue in place by the end of July, and essentially working into to be able to have sponsors who use the National Product Catalogue to send data or who would like to use the National Product Catalogue to send data into the Unique Device Identification database, that you can start to do some of that testing.

In addition, the machine-to-machine technical work has been completed. It’s really, the current processes or the current steps that we have at the moment, we have because the machine-to-machine interface is using an international standard, Health Level Seven Structured Product Labelling (HL7 SPL), which is consistent with what’s being used in the United States Food and Drug Administration.

We actually are getting international certification and review of that specification that we’ve developed at the moment, and that’s currently in the process. Once that’s finalised, and which we’re hoping to be in the next couple of weeks, we’re looking to have that published, and then have sponsors available, testing that interface as well, if you choose to use the machine-to-machine interface.

So that’s progressing really nicely and certainly in a point where, certainly through the August period, we’re expecting to be able to have a version of the net data dictionary published and available, but also then for sponsors to trial and test either the National Product Catalogue and/or the machine-to-machine interface as part of their interactions with the Australian Unique Device Identification Database.

In addition to the technical work, we’ve actually made a number of changes and refinements and refreshing of the Unique Device Identification Hub on the Therapeutic Goods Administration website. We have ensured, since the last webinar, that all the responses to the third consultation paper, which closed at the end of last year, are up for you to see, and visibility, as well as providing a summary.

We’re also looking at… We’ve refreshed elements of the Unique Device Identification Hub and the Therapeutic Goods Administration website around Unique Device Identification, and we’re in the process now of establishing a constant refresh regime to ensure that we’re keeping the information, and particularly adding frequently asked questions and ensuring that a lot of the questions you’re asking now is available through the Therapeutic Goods Administration website so that it makes it easy for you to access information.

So there have been a number of changes that have occurred, and certainly we intend to see more changes over the coming months to ensure that there’s a current update.

And finally, we hosted, certainly in June, two face-to-face workshops, one in Sydney on 9 June and one in Melbourne on 16 June, with a number of sponsors. And we deliberately focused on sponsors as part of that conversation, because we’re looking to get sponsor feedback on a number of things around the policy intentions and what we’re looking at around unintended consequences for those workshops.

We had nearly 300 sponsors participating. And essentially, we had what I think was a very valuable session that was covered with sponsors, and it provided a lot of valuable feedback around the Unique Device Identification implementation, the policy intent, unintended consequences. And I’ll talk through a little more as part of this session.

So, as I mentioned, really at this point, since our last webinar, we’ve got a lot of activity. It’s starting to bring together both technical aspects of the Unique Device Identification database and its implementation as well as finalising some of the policy and the intended implementation considerations for the Unique Device Identification. And over the coming months, we will start to see that come together and ensure that any policy changes are reflected in the Unique Device Identification database, and vice versa.

The other final thing I just wanted to stress, and where we give guidance to sponsors in particular, and manufacturers, while we’re still finalising the formal arrangements for the issuing of Unique Device Identification device identifiers within Australia, I really wanted to highlight for sponsors that if you don’t have Device Identifiers allocated to your devices, then we are looking to establish and formalise the arrangements with the three Issuing Agencies that are used globally.

So certainly, the United States Food and Drug Administration and the European Commission in terms of being able to use those Issuing Agencies for Australian Unique Device Identification Device Identifiers. So, as we’re formalising that arrangement, we will be documenting more and putting that onto the Therapeutic Goods Administration website.

But we would like to highlight now and use this time to highlight to sponsors and manufacturers that we’ll be looking to encourage and support the use of Device Identifiers, where applicable, from Europe or United States Food and Drug Administration, using the labelling that is used in the United States Food and Drug Administration and Australia, provided they still fit within the Australian regulatory environment.

And Device Identifiers on those labels, issued by GS1, Health Industry Business Communication Council or International Council for Commonality in Blood Banking Automation, will be accepted within the Australian Unique Device Identification environment. As I mentioned, the formal arrangements are still being finalised with the Issuing Agencies, but we’ve had really good conversation with them over the last month and a bit to get the arrangements in place.

And if a sponsor or manufacturer is interested in understanding what the implications or what the requirements are for them to be allocating a Unique Device Identification device identifier, we would actually… The Issuing Agencies are actually ready for your calls and be happy to take your queries in terms of how that would be dealt with in the Australian context.

So certainly, if there’s any questions you would like to raise around the Issuing Agencies and what we’re doing, feel free to continue to raise them through to the Unique Device Identification help desk, but also then feel free to contact or be in touch with any of those three Issuing Agencies that you see on the screen in front of you, and they’re very keen to start helping guide you through that process.

And over the coming months, we’ll formalise, through the Therapeutic Goods Administration process and Therapeutic Goods Administration website, what those notifications are. But you can go forward with confidence that those three will be three Issuing Agencies that will start to… Will form the foundation of Australian Unique Device Identification implementation.

So just the headlines and the highlights. So, the next step is I want to just give you a bit more specifics, because there are a number of questions and topics that came from our face-to-face workshops, so I wanted to talk you through those. And it’s really where the focus of our regulatory considerations are now, and so to be able to talk through what’s likely to be happening in that space.

As I mentioned, we hosted the two face-to-face workshops in Sydney and Melbourne. We had really great interaction and engagement from the sponsors. And the whole aim of those workshops is really to ensure the understanding of the Australian policy position on the Unique Device Identification implementation.

So that one of the things that we were finding, we had a great representation from small, medium, and large manufacturers and sponsors to be able to understand and talk through the implications of the Australian Unique Device Identification and ensure there’s consistency of understanding from the sponsor community around the implications of Unique Device Identification. And we certainly had great interaction with sponsors around what that would mean and particular device types.

We also used the workshops to discuss any challenges and implications and/or unintended consequences of the Unique Device Identification implementation, with the lens of really looking at it from the industry, so the medical device industry, and being able to ensure that from a sponsor and manufacturer perspective, that we understood if there was any unintended consequences or if there are other implementation considerations, but also from the Therapeutic Goods Administration’s perspective as well as the end consumers.

So, we looked at the challenges of implementing Unique Device Identification from all those angles, and we had some great feedback and some further actions that came out of that as part of that conversation.

And then, finally, was to inform the regulatory guidance documents before final drafting. Through the workshops, we had a lot of common themes across Sydney and Melbourne, but we also had a lot of different themes, depending on the different sponsors that were participating.

And had great representation on a number of issues or a number of device types and questions that sponsors were asking around how Unique Device Identification may apply to their particular circumstances, and really helping inform us around what we need to include in the guidance documents, as well as providing specific examples around types of examples we would put into the guidance document to ensure that we could bring it to life and ensure that our Unique Device Identification understanding is shared across the industry.

So, as I mentioned, we had nearly 300 sponsors that participated. We very much deliberately focused it on sponsors, because at this stage, we’re looking to… We’re talking through, as I mentioned, the consequences of implementation of Unique Device Identification on the medical device sponsors and manufacturers and used that session to talk through that.

In future periods, we’re looking to start to put more information out and share information for healthcare providers, other consumers, many other healthcare organisations, other stakeholders within the healthcare system, around what Unique Device Identification is and what that means, and the implications for that. But really wanted to get that foundation focused on sponsors in the beginning. So, we felt that it was a really valuable session, and it certainly was useful from the Therapeutic Goods Administration side.

And out of that workshop, we did take away a number of action items. And there was certainly work that we had to perform, and there’s work that’s now underway within the Therapeutic Goods Administration team to actually look at some number of considerations. So, we’ve grouped those considerations into really the six groups that you see in front of you.

And I won’t talk through all of them, but it is something that I really want to highlight, that there is still some work, and there’s some work that’s still currently underway for us to refine and make some refinements around the policy intent, and then use that to inform the government around considerations that they are taking for the Unique Device Identification implementation.

So, the first one to highlight was implementation options. We had lengthy conversation and had great working sessions both in Sydney and Melbourne, with sponsors, around the impact of the European Medical Device Regulation and the timing of that, associated with the timing of Unique Device Identification here in Australia.

And really looked at a number of options around how that could be dealt with, and certainly the concerns from sponsors around the likely load and burden on them in relation to meeting compliance for European Medical Device Regulation, ensuring that the data coming from Europe or from manufacturers based in Europe and supplying European devices was valid and accurate and could be supplied to the Therapeutic Goods Administration, as well as then other implications.

Out of that session, we actually had taken away to do some work around consideration of implementation options. And we’re currently working through that internally within the Therapeutic Goods Administration. And those options considered simplifying the process to be able to ensure that sponsors could meet some of the requirements for Unique Device Identification, but because there was an amount of change that was going on across Europe, to ensure that that was less burdensome on them.

So, things like the trigger fields and simplification around trigger fields, looking at what’s mandatory and what’s not mandatory within the Unique Device Identification database, and maybe, over time, actually starting with a simple set of data fields that are mandatory, and then, over time, extending that out to meet some of the other Australian requirements.

In that process, we also looked at the Consent To Supply. And I know we had some questions as part of the pre-registration process around understanding Consent To Supply and what that would mean, and some great suggestions that the Therapeutic Goods Administration is now considering around how we can streamline, and potentially one of the options around simplifying the Consent To Supply, and using a notification period to ensure that we don’t create additional burden for the Therapeutic Goods Administration and sponsors around how we deal with devices that may not have all the data or may not be able to meet all the requirements that are there.

And then also looking at, we had some feedback around the proposed implementation dates for In Vitro Diagnostic devices. And as part of that work that we’re doing now is to look at the timing and possible considerations for how we split up the implementation periods and dates for In Vitro Diagnostic devices. So that’s work that’s really working through at the moment, and we’ll continue to work through within the Therapeutic Goods Administration, and then consult out with various groups as we’re going.

The other things that we’re looking into, we had some feedback around the understanding of how the… The implications and impact of Surgical Loan Kits and device identification for loan kits, as well as System And Procedure Packs, and what that would mean within a healthcare and hospital setting. And we’re looking to commence that work to understand what those implications are, what that would mean for healthcare, and also then the Unique Device Identification requirements for retail products.

We had some good discussion around that, and then certainly the Therapeutic Goods Administration took away some work to be able to understand and provide clearer guidance around the implications of Unique Device Identification for retail products, and then whether there’s considerations for labelling from other countries, and particularly Japan. And so certainly our going-in position was to support the European and US compliant labels, and certainly one of the requests was could we extend that to other countries. So, the team is looking at that.

In addition to that, we had some feedback around the Australian Unique Device Identification Database and how that would operate, in particular around the management of corrections, the Global Medical Device Nomenclatures and the use of multiple sponsors for the same medical device. So, there’s some work that we’re doing and continuing to work within the Unique Device Identification database and how that’s being implemented, and that will continue.

And we’ve already started to see, through some of our engagements, and those of you who participated in our technical working group last week, we started to share and present some information about the options, for example, around how to deal with corrections or how we’re thinking about managing corrections and changes during grace periods. So that will continue.

Therapeutic Goods Administration integration, which, as I mentioned, there’s some implications for Consent To Supply, so looking at how Unique Device Identification may impact that process, but also some of the other Therapeutic Goods Administration processes, such as reports of adverse events and the single audit program, Medical Device Single Audit Program.

And finally, the two final components that really came out of the workshops were really about information, definitions, examples of guidance documents that we can start to develop and taking that information to ensure that there’s a nice, concise and clear set of documents to support you and likely avoid a number of those questions that you may be asking around what does Unique Device Identification in certain circumstances.

But also ensure that what support teams… What support arrangements we have in place, building on the support team we have, to be able to ensure that there’s user guides and other support products that can help inform you about the Unique Device Identification implementation.

And so out of all of that workshop, there’s still a lot of work to do. The team is well-progressed on progressing through that and working through it, but the workshops were really valuable in particularly helping us. The items I’m talking about on the left-hand side in blue is really where our key considerations are. And what we’re proposing to do and what we’re working on now is really the timeline that we’re looking to get that in place.

So, between now and the… Certainly started in June, now and then the end of August, we’re finalising and doing some further consultation around understanding those implications, talking through with sponsors as well as other stakeholders around the implications of those impacts and considerations, and using that to then inform some of the position for government, to help inform government and make them… To allow them to make their decisions and provide their guidance to us around the final Unique Device Identification implementation.

From September through to November, really using that time to finalise the drafting, ensure that the drafting instructions and the information that goes to the regulations will have the Unique Device Identification amendments to the Essential Principles, and then the other supporting regulatory instruments, to ensure that we have the Unique Device Identification rolled through that, and it’s clear and concise.

So that will happen between September and November, again with the aim of having… Well, December 2023, have the regulations in effect. And from that point in time, we’ll have our Voluntary Compliance version of the Unique Device Identification database available at the same time. So that’s really where we’re looking forward.

So, we’ve now broken that work into a number of stages, and the team is well progressed and progressing through each of those questions in all the topics. We have started, and we do talk to a number of different industry stakeholders. And some of you will see some of those questions and some of that consultation come up over the coming next few weeks.

So, thank you. I just wanted just to pause there and thank you for… If there are any questions, please feel free to raise them. Add them to the Slido. And I would like to then hand over to Bruce, who can talk you through the Australian Unique Device Identification Database Pre-Production environment and provide examples and an illustration of how the Unique Device Identification system works. Thanks, Bruce. Over to you.

From September through to November, really using that time to finalise the drafting, ensure that the drafting instructions and the information that goes to the regulations will have the Unique Device Identification amendments to the Essential Principles, and then the other supporting regulatory instruments, to ensure that we have the Unique Device Identification rolled through that, and it’s clear and concise.

So that will happen between September and November, again with the aim of having… Well, December 2023, have the regulations in effect. And from that point in time, we’ll have our Voluntary Compliance version of the Unique Device Identification database available at the same time. So that’s really where we’re looking forward. So, we’ve now broken that work into a number of stages, and the team is well progressed and progressing through each of those questions in all the topics. We have started, and we do talk to a number of different industry stakeholders. And some of you will see some of those questions and some of that consultation come up over the coming next few weeks. So, thank you. I just wanted just to pause there and thank you for… If there are any questions, please feel free to raise them. Add them to the Slido. And I would like to then hand over to Bruce, who can talk you through the Australian Unique Device Identification Database Pre-Production environment and provide examples and an illustration of how the Unique Device Identification system works. Thanks, Bruce. Over to you.

Bruce Thomson

Thanks very much, Gary. Hello, everyone. Thanks for joining us today. I’m going to be giving an overview of the main features of our online Australian Unique Device Identification Database Pre-Production environment. The environment can be used to preview the features that are going to be made available prior to Production, as well as being used to establish that any machine-to-machine interface that you may create can appropriately make requests and receive responses from Australian Unique Device Identification Database prior to you being able to register for Production access.

Now, I realise that not all of you will necessarily use the online portal to add Unique Device Identification records, but you can certainly use it to view records and also to be able to see what the public will be able to see. What I’m going to demonstrate via the online portal is two main things, how to manage your Unique Device Identification records, including how to link an Australian Register of Therapeutic Goods entry to an existing device, and also to show you what public access is available once the Production system becomes available.

The login procedure, firstly, for the Pre-Production environment is similar to our Production system, with one key difference. And that is, the Pre-Production login will take you straight to Australian Unique Device Identification Database rather than first logging into the Therapeutic Goods Administration Business Services.

When you first indicate your interest in participating in Pre-Production, you’ll be given a login link. The login starts with this page, where you’ll select Login with Therapeutic Goods Administration. You will log in using your Therapeutic Goods Administration user ID and password, and this user access will have been set up by whomever has the administrator role for your organisation.

Once you log in, you’ll be taken straight to Australian Unique Device Identification Database. In this particular example, the organisation that I’m using is both an agent and a sponsor in their own right, and I select the organisation that I am dealing with in this online session. And once confirming the organisation, I’m taken to the home page of our Pre-Production system.

The next feature is the My UDI Records. It is a feature that allows you to view all the medical devices for which you are the sponsor. The results can be filtered by keywords. Sorry, I’ll just pause that for a moment. The results can be filtered by keywords such as brand or model or version, Global Medical Device Nomenclature term name or even the Australian Register of Therapeutic Goods number.

Selecting the primary link, Primary Device Identifier link, will open up the medical device information, such as this page here. And the information is split into various sections. We have an overview that shows things like the Australian Register of Therapeutic Goods number that the device is included under, and then, variously, sections for device identifiers.

That indicates all of the other device identifiers associated with this device. General device information, such as brand, catalogue number, device class. The clinical characteristics, whether it’s for single use, etc. The manufacturer details. The Australian Register of Therapeutic Goods entry that it’s included under.

The Global Medical Device Nomenclature that’s been selected for this device. Any packaging that has been set up for the device. In this instance, I haven’t set anything else up. The production information, such as whether there’s a lot or batch number on the label. Any supporting documents for the device.

If you use the online portal to add a medical device, you would use this particular option, Add UDI Record. This opens up the medical device information screen, where you can add relevant information. The information is added once section at a time.

And as you go through adding the information, there are validations that are shown as you work through the section. In this case, I’ve put in an incorrect check digit. Elements are shown as mandatory by indicating with the blue asterisk that you can see there, and check boxes are shown for a number of our yes or no questions.

So, it’s a matter of working through this section one at a time, one section at a time. Elements are shown as mandatory, or errors are shown where the data is not valid. Dropdown lists are shown for important fields such as device class. We also have it on the Magnetic Resonance Imaging safety status. We also have a number of yes and no fields as well.

On this particular screen, it also has provision for you to enter details such as device packaged as sterile and requires sterilisation prior to use. One of the checks that we’ve put in place is that if you indicate, for example, that it requires sterilisation prior to use, another element pops up, asking you to select the particular sterilisation methods.

So I can choose the sterilisation method that’s applicable. If I uncheck the requires sterilisation prior to use, then that sterilisation box is removed. And I can also add the clinical sizes and storage methods, storage and handling method. On the Associate a Manufacturer screen, you would use the Therapeutic Goods Administration Business Services organisation number used to select the manufacturer. This is the same number that’s used in the Australian Register of Therapeutic Goods system.

Moving on to Australian Register of Therapeutic Goods IDs, the Australian Register of Therapeutic Goods number if validated to ensure that the Australian Register of Therapeutic Goods sponsor and manufacturer that you choose matches the Unique Device Identification sponsor and manufacturer. So you’re not able to add just any Australian Register of Therapeutic Goods number. It must match with sponsor and manufacturer for your device. For the Global Medical Device Nomenclature terms, you can search by text or by code, and that’ll bring up a list of the matching Global Medical Device Nomenclature terms for you to choose the one that’s appropriate for this particular device.

If your device is included in a higher level package, you can configure the package details on this page here. Each package requires its own device identifier. You can nominate the name or type of package, whether it’s called a box, a bag, a case or some other description that is relevant for you. You indicate the number of items that are in that particular package, and then you can create the package. This section here is to include the elements that make up the production identifier. There’s a section I’ll talk about later for supporting documents.

And then lastly, you can save. Once you’ve gone through all the sections, you can save the draft for later, you can publish it, and you can publish it either immediately or set it to a future date. Now, if I return to My UDI Records, you can see that I’ve… Sorry, it skipped ahead. If you go on back to My UDI Records, you’ll see that it’ll actually display the record that you’ve just created. I do want to show on this slide here that you’re able to search for… That when you search for devices, that you’re not just restricted to just using the Primary Device Identifier. If your packaged device is contained within, say, a box that has five items, then the box has its own Package Device Identifier that I used in the previous example. You can use that identifier to retrieve the details of the medical device that’s contained within that package.

So, on this particular screen, I’ve entered this number, which is the package device identifier. It’s returned a device that on the surface does not seem to match on the Primary Device Identifier. But that’s because this device that I’ve entered is actually one of the packages within this device. So I continue. If I select the device and then go to the packaging section, then the number that I searched for is shown on the screen there. So I’m able to search not just for Primary Device Identifiers but for Package Device Identifiers as well. I can search for packages via a number of ways. I can use the Devices menu as well as the search on the Home menu. This is just another example of bringing up the same package. I might stop that one now.

The next feature that I’d like to show is how you as a sponsor can add an Australian Register of Therapeutic Goods identifier to an existing medical device, regardless of who added the device. Now, an Australian Register of Therapeutic Goods identifier can only be added to a device that’s already been published. So, in this case, I would select the Link ARTG Details.

And I can filter the results to display the devices that I’m interested in. It’s as simple as selecting the Edit ARTG ID box and then entering the Australian Register of Therapeutic Goods identifier that is relevant for this particular device. Validation occurs to ensure that the sponsor and manufacturer of the Australian Register of Therapeutic Goods entry matches the sponsor and manufacturer of the Unique Device Identification record. If it doesn’t match, you receive the error messages shown there.

When I enter the valid Australian Register of Therapeutic Goods identifier, then I’m able to save that particular Australian Register of Therapeutic Goods identifier and have it linked to the record. You can see that both Australian Register of Therapeutic Goods identifiers are now shown. The same process can be used to remove, in certain circumstances, the Australian Register of Therapeutic Goods identifier, only if it should not have been added in the first place. So, you can see that the Australian Register of Therapeutic Goods identifier is now gone.

For the online portal, it is possible to save the medical device as a draft. Selecting the Drafts option shows you the medical devices which are in draft so that you finish editing them and publish them. The Continue Edit button will bring up the sections within the device, and you can complete all of the sections in a similar way that I’d shown when you first added the device.

Saving the record, when you finish adding the sections, you can save the record either as draft or you can publish the record or you can delete the draft record. All of those options are available.

We have a number of ways of adding supporting documents to a medical device. The online portal allows documents to be added as an attachment or as a URL. At this stage, our security restrictions limit us to accepting PDF documents only. For our other channels, such as the bulk spreadsheet upload, National Product Catalogue or machine-to-machine channels, we only accept a URL link. We’re not accepting attachments via these channels.

Within the portal, we can add documents one device at a time, or the other way is to use our new bulk feature, which allows a document to be added to multiple devices at a time. Now, that’s the purpose of the Manage Documents option and the screen that’s shown.

When the screen is first displayed, it will show all of your medical devices for which you have supplied an Australian Register of Therapeutic Goods number. Now, since this is only shown to sponsors, it will only show the details for the logged in sponsor. The top half of the screen is where you can filter the medical devices to select the ones which you wish to add, replace or delete documents. The filter by keyword allows you to select by manufacturer name or brand or model or version or Global Medical Device Nomenclature. The middle part of the screen shows the action buttons that will be enabled once you have selected one or more devices to add a document to, or you can replace or delete specific documents. So, this is an example of adding a document. The filters show that I am dealing with a Patient Information Leaflet. I’ve requested to list all of my documents that do not currently have a Patient Information Leaflet. In this case, there are two, sorry, devices, and I’ve selected those devices.

Selecting Add a new document to two devices will bring up this modal. The model allows me to choose between a URL or an attachment. In this instance, I’ve chosen a URL link and have added the URL. If I had chosen attachment, I would be given a drag and drop screen to select a file to be uploaded. And selecting the Add document from this screen will link the URL to the two devices that I had selected on the previous screen.

Within the online portal, it’s possible to do a bulk upload of medical devices via an Excel spreadsheet. This could be used if you have up to 100 devices to add, and the devices can be included in the spreadsheet. We have provided a template, which is available under the Bulk Edit UDI option.

The template, which I’ve pre-filled in earlier, is divided into various tabs and includes all of the elements that are required. There is pop-up help available for various columns and some basic validation, including drop-down lists, such as the device class. There are drop-downs for basic yes and no fields, and also others such as the Magnetic Resonance Imaging safety status. It’s just a matter of completing the template for each of the relevant sections and then saving your template.

Once the template has been completed and saved, the template can be dragged back into the Bulk Upload page. Once it’s dragged back into that box, the file is validated and any errors are displayed. So that allows you to return to the spreadsheet, open up the file again and fix the errors.

So again, dragging the file into the box will again validate the particular template. And where there are no errors, you can then select Upload UDI Records. In this instance, I had one record uploaded, which I can now see by selecting My UDI Records.

The last group of features that I want to show are ones available to the public. This could be consumers, hospitals, clinicians, anyone who doesn’t login to the Australian Unique Device Identification Database. One of these options is Find Supporting Documents. This will allow the public to use Australian Unique Device Identification Database to search for Patient Information Leaflets for medical devices. Only medical devices for which a sponsor has uploaded a Patient Information Leaflet will be displayed. And as before, the list can be filtered on various keywords.

Once a medical device is selected, the supporting document section for the device is displayed. This will show the existing documents that have been associated with the device. Selecting the View link against each one will either navigate to the URL link, if one was provided, or it will download the attachment, if it was provided.

In this instance, since I’ve logged in as a sponsor for this device, I can see the Edit Device button, which will throw me into an edit mode and allow me to add, replace or delete documents for this individual medical device. If I am not the sponsor for the device, I can’t edit the device. And as a member of the public, I would not see that Edit Device option.

The last feature I want to show is that anyone can view and download devices from the Australian Unique Device Identification Database. If I were to search for devices, in this case using the keyword, cardiac, I would be shown matching devices. I’m able to select one or more of the devices and then choose to export those records.

My choices are to export the full record or just to export the search results in various file formats. I can search via the Home page, or I can search via the Devices page. Keywords, as I’ve mentioned before, can include manufacturer name or could include part of the Global Medical Device Nomenclature term name. There is also a rudimentary feature that allows your device camera to scan a barcode or enter it manually to retrieve the details of that medical device. Once found, in that example, it’s not found, but once found, you can view the details for that device.

Lastly, you may have a need to download all of the medical device details. Under the Download options, there is the ability to download the full current version or previous version as well as to download only the medical devices for which there’s been a change in the last day, week, or month. This is provided so it can be integrated or compared with your source systems.

As you can see, that brings me to the end of this section. So, I’ve shown you how you’re able, via the online portal, to add records one at a time, to add devices as a draft and to retrieve and edit your changes and to publish them, to view your published records and make further changes, to add Australian Register of Therapeutic Goods IDs to other existing devices and to upload and manage patient information leaflets.

Also, I’ve shown how the public is able to view all published devices, to export selected devices via a number of file formats, to download either the full database or the latest daily, weekly or monthly changes, and also to find supporting documents.

I really appreciate your attention. There was a lot that I went through there, which you will be able to see later on in replay of the presentation. So, thank you very much. I’ll hand back to Gary.

Gary Pascoe

Thanks, Bruce. Just really wanted to wrap up the work that Bruce has done, and I think there was a number of questions that were coming through as part of the chat as well as the Slido. We have the UDI@health.gov.au mailbox. That is our support team.

And essentially, any questions that have come through… So, we’d encourage you to raise any other questions that may come up outside of these sessions, but you think, well, how does that apply to my context and my situation, what does that mean, the support team responds to those questions and provides an answer in really a reasonable time. So, feel free to use that email address as we’re going. So given that we have a number of questions coming through, and we haven’t got a lot of time, I might unfortunately be a bit judicious with some of the questions, the responses to questions. So, we had a couple that were asked in relation to how you get access to the Pre-Production version of the database. Please feel free to send an email to UDI@health.gov.au to be able to access the Pre-Production. So, it is available to sponsors at this point in time.

We are limiting it to sponsors or their representatives from manufacturers, really to ensure that we have that version of the database right. So, if you are a consumer or somebody who is not a sponsor, then we are looking to introduce that access to Pre-Production, but that will be later in the year, so that we can ensure that we’ve got the data in the database that is usable and accessible. So, as I mentioned, UDI@health.gov.au is the… Send us an email, and the team will very happily give you access.

I’m going to flick through. So, there was a question around the Voluntary Compliance dates and what was being… When Voluntary Compliance might start, and essentially then what that would mean during the Voluntary Compliance Period, and then Mandatory Compliance from that point on. So, as I mentioned, we’re aiming for, again subject to the final government direction, really December of this year to have Voluntary Compliance take effect.

From that point onwards, actually, the intention is to have 12 months for a Voluntary Compliance Period for sponsors, if they choose to, to submit Unique Device Identification data and to have devices supplied with Unique Device Identification labels, coming in and being supplied to the Therapeutic Goods Administration for any device class. So, it’s really a period of time for sponsors to start to provide the data, get themselves ready and familiar, before it becomes mandatory from the Mandatory Compliance date.

We are working through the considerations for Mandatory Compliance and when they would start. We’re essentially looking at… Our approach is to have a progressive roll-out of Mandatory Compliance via device risk class, with the high-risk devices, Class III, Class IIb devices, to take effect 12 months after Voluntary Compliance. So, if we’re looking to go forward from December 2023, then from December 2024 to have Mandatory Compliance for high-risk, and then effectively a 12-month roll-out period from there as we work through the other device classes.

Based on our feedback from the workshops, we are looking at the implications of those dates and what we may be able to do to support or ease some of the burden, in addition to, as I mentioned before, what those dates may imply for In Vitro Diagnostics, because we have had some feedback around considerations for splitting up some of the In Vitro Diagnostics dates. So that’s working through, and we’ll provide notification of that once that’s confirmed by government.

Bruce, I have a question for you. From your experience so far, how long does it take to complete an entry in the Unique Device Identification database?

Bruce Thomson

What we have found is that because we’ve been using the system a lot and using mainly test data, you can actually go through all of the screens fairly quickly. I think our testers have it down to about two minutes. More importantly, the question is, it is a straightforward process if you already have the information available. If you have to stop and go and search for further information, then yes, it will take you longer. But it’s only a matter of a number of minutes to enter the data.

Gary Pascoe

Thanks, Bruce. I wanted to say we’ve actually hit time, so I might just… One final… Some final questions coming down from… Have come to me. The question was, will all manufacturers with medical devices be added to the drop-down list for manufacturers?

And wanted to say those who are actually manufacturers and sponsors who are using and registered within the Therapeutic Goods Administration Business Services systems and essentially those manufacturers who currently supply devices that have been authorised for supply here in Australia, that information will be in the Therapeutic Goods Administration Business Services system. So, we will draw that information from Therapeutic Goods Administration Business Services.

So, by moving it into the Health environment, one of the challenges or changes that have occurred since we’ve gone to Pre-Production is to have that capability in place so that we’re able to use the existing information so that drop-down would be populated with the manufacturers that currently supply devices to Australia.

So, look, I just see there’s still a number of questions still coming through. So, we might just wrap up here. We’ve hit time. And wanted to say thank you for your time and for your contribution. Those questions that are still coming through, we are looking to… We will be responding to them.

So, we’ll provide a response to those questions as we’re finalising the material from the webinar. We’ll be making it available in the coming weeks. So, we’ll essentially take that information and publish it on the Therapeutic Goods Administration website, and we’ll provide you with notification once that webinar video and the transcript is available. So again, thank you very much for your time. Really appreciate your contributions, and wishing you all a very nice day.