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Webinar presentation: Unique Device Identification Webinar #5

26 October 2021

Disclaimer

These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Allison Mehr, Vice President HIBCC and Michelle van Wijk, Unique Device Identification Project Manager, TGA
  • Presented at: Online webinar
  • Presentation date: Tuesday 19 october 2021
  • Presentation summary: A presentation on the role of a UDI Issuing Agency, including project update and Q&A. Issuing Agencies are responsible for creating unique device identifiers according to globally recognised standards. This session follows on from Webinar 4 and will include a presentation on the UDIs generated by the Health Industry Business Communications Council.

Recording of online webinar presentation

Transcript

Speaker Key

MVW - Michelle van Wijk (TGA)

AM - Allison Mehr (HIBCC)


MVW

Good morning everybody and welcome to our 5th UDI webinar. I'd like to begin today by acknowledging the Ngunnawal people, the traditional custodians of the land on which we meet today and pay my respects to their elders past and present. I extend that respect to Aboriginal and Torres Strait Islander peoples here today. Today's presentation we have our invited guest speaker, Allison Mehr from one of the issuing agencies that is used in the U.S. and EU and other areas for example. We'll give you a progress update and we'll provide some questions and answer time at the end.

Right now, what I'd like to do is introduce Allison. Allison has very kindly offered to join us today to provide more information around the issuing agency process from the perspective of a second industry issuing agency which is the Health Industry Business Communications Council. And that is an industry supported and internationally accredited non-profit standards development organisation.

Allison specialises in international medical device regulations and is the key HIBCC point of contact for the European Union's Medical Device Regulation, the MDR and In Vitro Diagnostic Regulation, which is the IVDR, and also the US Food and Drug Administration's Unique Device Identification Rule. Allison oversees the maintenance of the health industry barcode at the HIBCC and the Supplier Labelling Standard, the SLS and its application in medical device regulations globally.

Allison works directly with industry stakeholders to provide technical specifications and strategic guidance on the implementation of the HIBCC standards. And so, I'd like to now hand over to Allison and thank you Allison for your presentation today.

AM

I'll go ahead and get started. For this presentation I'm going to start with a brief overview of HIBCC, we typically refer to it as HIBCC, it's a little bit easier to say, and key characteristics of our Supplier Labelling Standard which is used globally by our labellers to comply with UDI regulations. Then I will cover how to register with HIBCC, the structure of the HIBCC device identifier and then some of the online utilities that HIBCC provides to assist our labellers in UDI creation.

You'll notice that I'll use the term labeller throughout this presentation. Labeller refers to an organisation that causes a label to be applied to a device. Generally this would be a manufacturer but in some cases it could be another organisation such as a distributor or an importer or a re-labeller.

A little background on HIBCC. We are an internationally accredited non-profit standards development organisation that exclusively focuses on health care. We were originally founded in 1983 with the mandate to develop the barcode labelling standard for tracking health care products through the supply chain.

This was when the HIBCC Supplier Labelling Standard was actually developed. Now the standard has been updated over the years to incorporate new technology and new regulatory requirements especially with the introduction of the UDI. However this is the same standard that is used today to satisfy those UDI requirements, so the standard has been around for quite a while.

Over the next several slides I'm going to go into more detail about the HIBCC UDI structure and format. But first it's really important to understand two of the key characteristics that distinguish the HIBCC standard. One is that the HIBCC standard utilises an alphanumeric dataset. The second is that the standard contains variable length fields, specifically for the product or catalogue field, the lot and serial fields.

The alphanumeric dataset provides the largest set of possible identifiers for our labellers and when that's combined with the variable length fields this allows labellers to encode existing product or catalogue codes, serial numbers and, or lots directly into the UDI. So this literal encoding of the product data it eliminates the need for cross referencing.

It simplifies the UDI process for labellers, the assignment process and it really ultimately reduces the risk of errors because you're not having to create a new identifier for your device. This is the same reason that other industries with a high concern for consumer safety such as the automotive industry utilises alphanumeric identifiers.

In order for an organisation to use the HIBCC standard for UDI the first step is that they have to obtain a company prefix. This is what we call a labeller identification code or LIC. That is what it is called on our website if you're going through the application. This is the first step in the UDI process. The company prefix will be the beginning of every UDI created by an organisation. Now there is a one-time fee associated with that company prefix which correlates to the organisation's global gross sales. It's a true one-time fee, we always get that question, with no annual renewals or maintenance fees.

It's also important to note that HIBCC's company prefix fee structure is not affected by the number of the UDIs that need to be created. That is another question that we frequently get what does it cost if I were to create this many UDIs. For the HIBCC company prefix you just pay that one time and you can create as many UDIs as you need to for your organisation. Additionally, an organisation can use the same LIC globally for all of their products. The LIC is specific to the organisation or trade name and not a specific country.

However there are some instances where an organisation will use different brand or trade names for different markets and they wish to keep that separate. In those scenarios they may have an LIC for each trade name. HIBCC does maintain a single centralised database of all LICs. There is only one database that we maintain which we provide to regulatory bodies and they use that to confirm the data that's submitted in their official UDI databases.

For example right now for the US because that is really the only UDI regulation or market that has a populated UDI database so we do provide that list of LICs to the FDA and they use that to match it against the data that they're receiving for the Device Identifier entries. And we do go through that as well and look for errors or misstatements or something like that.

Now I want to get into the actual structure of the HIBCC UDI which I think will be helpful in understanding the UDI allocation and assignment process with HIBCC. There are really two components to the UDI, the device identifier and the production identifier. You can think of the device identifier as the mandatory fixed portion of the UDI which is what I'm going to focus on because it applies to all devices that are subject to a UDI regulation, while the production identifier is variable or conditional and that is the other portion of the UDI.

A HIBCC standard contains specific data identifiers also called application identifiers that tell the scanner or whoever is looking at the barcode what field of data follows. The majority of those data identifiers are used in the production identifier portion, so for example lot or serial, expiration date, things like that which we won't extensively go into in this presentation. But I did provide a link at the end of the presentation to the HIBCC Supplier Labelling Standard which details all of the possible data identifiers that are included in a HIBCC standard.

The device identifier. This is the first portion of the UDI. This is what you will be submitting to regulatory databases. Both for the US and the European Union UDI regulations they only require the submission of the device identifier and not the production identifier. The device identifier, this is also referred to as the primary data structure in the HIBCC standard but just know that those terms are really interchangeable, they mean the same thing.

The HIBCC DI identifies, the organisation, the specific model or version of the device and the package configuration. You'll notice when you look at this example that I've included that there is a plus sign that precedes the LIC. The plus sign is the HIBCC flag character so this tells you that the UDI is in the HIBBC format. There is also a check character at the end of every HIBCC data string whether it is a DI or a PI there is always a check character at the end. That is just an additional security measure to make sure that the data entered is accurate.

The check character is calculated based on the characters that precede it in the data string. If you're using an online utility or labelling software or something like that generally the check character will be automatically calculated and I'll go into some screenshots of the online utility that HIBCC has which also automatically generates the check character for you.

And then in this example you will also note that I am using a linear barcode. That's not a requirement. A labeller can choose to use a 2D symbol such as a QR code if they wish. The actual data encoded remains the same regardless of whether you choose to use a linear or a 2D symbology. Typically the 2D symbologies like the QR code are used on packages with size constraints since it can be printed much smaller than the linear barcode. But either one is fine and they all work with HIBCC standard.

Now to get into the actual fields of the device identifier. The company prefix this is unique to each organisation or trade name and is assigned by HIBCC. It is never re-used and it is always four characters alphanumeric. And it also cannot be transferred to another organisation. However we do allow updates to the data linked to the LIC which would be on our LIC database, such as company name, contact information, address, things like that.

The next field in the device identifier, is the product or catalogue field. This field is assigned by the labeller. The parameters for the field are that it must be between 1 and 18 characters and alphanumeric. This is where HIBCC would recommend that the labeller use their existing product or catalogue codes or whatever is used to identify that particular device. However that's not a requirement and sometimes an organisation will choose to assign a new product or catalogue code. But for consistency purposes we would recommend that you use whatever you already use to identify that device.

And the last field of the HIBCC DI is the unit of measure or package level indicator. This is a single digit from 0 to 9 where 0 will always represent a single unit and 9 is reserved for devices with variable quantities. The remaining numbers can be used to identify all of the remaining package levels of a specific device in ranking order. And again this is something that's assigned by the labeller. HIBCC does have guidelines for how this is used though.

On this slide I won't get into all of the details for the purposes of time but there are a few examples of how a unit of measure can be assigned. The unit of measure field in the HIBCC standard was designed to allow the labeller to uniquely identify each packaging configuration without having to change the product or catalogue code. And you will see at the end of the presentation there's a link to a guidance document which includes a lot more examples and details about how you can actually assign unit of measure.

And we also do provide assistance to labellers if they have questions about how they actually assign the unit of measure or if they have a device that is a little bit more complex in how it's packaged. We do provide one-on-one support or assistance with that. The device identifier allocation rule, there is one allocation rule that is stated in the HIBCC Supplier Labelling Standard. And the current version of the Supplier Labelling Standard is 2.6 so any time there is an update that versioning would change. But we always keep the current version on our website.

If you have questions about past versions just let us know. Generally we try to keep them backward compatible so if you're following a previous version of the standard it's still valid going forward.

The one allocation rule that is stated in the standard is that the device identifiers should never be reissued to another product. HIBCC additionally advises all labellers to create new device identifiers in certain scenarios based on the current regulatory requirements. For example when there is a new variation of an existing device, rebranding or a new trade name, new packaging level, changes in sterilisation or storage requirements, a change in the device risk class, a change in the use certificate or approval of the device, anything like that.

But the general rule of thumb is that a new DI should be created whenever there is a change in form, fit or function of the device. And if you have questions we do assist our labellers depending on what market or country they are selling their devices. For example there may be different requirements for the US than the EU so we do work with our labellers to figure out how they navigate those two markets and what would cause a new DI to be created in the US it may not be exactly the same in Europe.

The production identifier which I won't go into a lot of detail on, this contains the variable information for the device which could include any of the following fields, lot, serial, expiration date and, or manufacture date. There are some devices that have specific regulatory requirements for how the UDI DI and PI are assigned that may differ from what I just went over. So one example would be software where the minor versioning will be included in the PI typically in the lot field in the HIBCC standard while the major versioning is included in the DI.

Generally if one of our labellers has a device with special UDI requirements like that we would work with them one-on-one in the assignment process to make sure that they are assigning that correctly And additionally for the production identifier, so generally how that would work is that if you have one or more of these fields elsewhere on your label you would also include it in the UDI. So if you generally include an expiration date and lot on your device labels you would be required to include that in the UDI. If you don't include that information you're not required to create it just for the purposes of the UDI unless you have a specific regulatory requirement.

The next few slides are going to include screenshots of the HIBCC UDI builder. This is the free online utility that HIBCC provides. It's available to all of our labellers, really anyone that wants to use it. It assists with the creation of UDI. It also has a calculate check character function as well as a link to the GUDID where you can insert a DI and it will pull up the information from the GUDID. Eventually we should have that same functionality for EUDAMED when EUDAMED is fully running. And even if you're not registered with HIBCC you can still create an account on this just to see how the HIBCC standard works.

The most used function on the HIBCC UDI builder is the create a HIBCC UDI utility. This walks labellers through creating a UDI. The labeller will input device data into the corresponding fields and the utility will correctly format the UDI with the data identifier's date, format and check characters.

This is an example of how the utility looks. It walks you through with a Wizard it will automatically pull up the information for the labeller so when you enter that labeller identification code it will pull up the address and name. It will ask you then to input the associated information, product catalogue code, unit of measure. And then it will calculate the check character. You can also create the production identifiers on this utility as well.

And this is just an example of what the output would be. So you will see in this example I included a 2D structure, a data matrix which is similar to a QR code just so you can see the variety that the utility offers. This utility does allow labellers to create real barcodes in 2D structures which they can save and place on their device labels or use any way they need to. Labellers are not required to use this data. We do get some questions about whether or not they have to use this utility to register information. It's really just a learning and helpful utility that we created for our labellers to help them understand our Supplier Labelling Standard. It's not a requirement but it is there for their use.

We also have some third-party organisations that do the physical labelling, that will register for the HIBCC UDI builder and create an account. Sometimes they will actually create the UDIs that way, sometimes they do that just to check to make sure periodically that their software is generating it correctly. If anyone in this webinar would like a demo account for the HIBCC UDI builder please let us know by email at info@HIBCC.org We will include a demo LIC in your account but you will have full access to all of the utilities that the tool has and you will be able to create sample UDIs and just generally see how everything works.

And a little bit about the support that HIBCC offers in regards to UDI. We do provide technical and regulatory support for our labellers. Some of the examples of this are label review or AIDC, so the barcode or 2D symbol review. And we provide regulatory guidance, technical support for the HIBCC UDI builder or any other software that they're using. Standard implementation, so if they have questions about assigning the unit of measure or something like that. We also host periodic UDI webinars and one-on-one training sessions as requested.

We actually have a UDI webinar tomorrow. You can still sign up for it. It's available on our website and you just register for a HIBCC UDI webinar but we do periodically do those, typically every month or every six weeks or so. And the last slide that I had was just the links to certain utilities and applications and forms on our website that I mentioned in the presentation.

MVW

Thank you so much Allison. Really appreciate that. And we'll make those links available in chat so you can see those there if you need to. And the presentation will be also included on our website if you want to go back and look at any of the slides. Appreciate you taking the time Allison to provide that information.

What I'd like to do now is to give you a little bit of a progress update and then to cover off some of the questions and answers we've received to date. We will cover some at the end of this session if there's still time but otherwise we continue to collect those and to provide answers to those as we go. If you happened to have missed a webinar we did start that process at the last webinar in September. At that webinar we had some information about the timing and some of the other decisions that have already been made. So if you did miss that go back onto the TGA website and have a look at those because we started that process already.

I wanted to start today by providing a little bit of an update from one of the UDI workshops that was held in September. In September the International Medical Device Regulators Forum and the Global Diagnostic Imaging Healthcare IT and Radiation Therapy Trade Association, DITTA, held a joint workshop on UDI and really with a view of that international alignment. So across all of the countries that are implementing or have or are about to implement UDI, how do we start to get those global benefits for device recognition and patient safety from harmonising and doing these in the same way?

I'd like to just give you a short update on that workshop. It had four sessions. A presentation on the IMDRF guidance. One session on country updates. Australia presented at that. We had a session on information from manufacturers where manufacturers presented on some of the challenges and considerations from a manufacturer perspective, particularly those global manufacturers who have to manage UDI regulations across a number of countries. And there was a bit of a panel discussion as well from those who were attending as panellists.

I've given you a bit of an idea of what some of those sessions were here but also the link there. All of the presentations are available on the DITTA page. I haven't seen the presentations as in the recordings of the webinar part yet though. And one of the first sessions was just around a reminder to everybody on the International Medical Device Regulators Forum guidance documents. Starting in 2013 and running all the way through to 2019, a range of those four documents, the intent of them, and what was included in the contents.

I wanted to really talk a bit more about this one in detail. This presentation was made by Zita Yurko who is from Philips but also is involved with the DITTA and some of the working groups particularly around UDI. And this presentation was a manufacturer's perspective and I think it's a really important one to look at some of those challenges across multiple countries. And so I've taken some of those slides and put the content in here today. Again if you wanted to go back to the original presentation it's on the DITTA site.

But really the presentation talked about seven issues affecting the adoption of UDI. Remember that's the piece that is after the regulatory and in healthcare in registries and hospital systems. And she talked about really from a manufacturer perspective the lack of harmonisation across jurisdictions that led to additional administrative burden on manufacturers around additional rules in regional databases that cause creation of new device identifiers when a data element is changed outside the rules for triggers.

A lack of direct translation between differing issuing entities, so the formats of the device identifiers are different depending on the issuing entities or issuing agencies. There are varying definitions of terms and concepts between jurisdictions and that is the difference between what might be a primary DI, what might be a model name or device name. We know that there are differences in terms around kits or procedure packs. Some of the regulatory framework is different but then some of the language used in UDI is different and means slightly different things as well.

She also talked about the auto capture. The barcodes, the QR codes for example how they differ and some of those are emerging without regard for how those are used in supply chains. You will have heard Dennis Black talk about things passing through, boxes passing very, very quickly through machines in supply chain and how fast they need to be read and how important it is that they're clear for those readers to read.

Also around direct marking and the differences between some of the regulations in terms of what's required in terms of direct marking. What's different if there is only a very small space for example. And a lack of focus on education for healthcare delivery organisations. That's really around providing information to help everyone prepare for the use of UDI in those systems which is required for the benefits. And what she said was these are contradictory to the spirit of the unique device identification and potentially hamper global interoperability of the UDI system.

She also said that industry's been slow to adopt the use of UDI for global purchasing processes and continues to use, and that ‘ref' is a catalogue number, a model or device number. The unique identifier is already being used from a purchasing perspective. And the issues are also affecting traceability of medical devices, adverse event reporting, global data sharing and transparency and ultimately result in inefficient processes, higher cost and a decrease of product safety.

She has a number of proposed solutions there and really that focus back on the IMDRF guidance and guidelines and a harmonisation of requirements against those. And particularly around use of data elements, data sharing for example. Proposing active participation in the DITTA workshop to discuss, which happened. And potentially some new work in progress to really support a globally harmonised approach and perhaps bring some of those documents up to speed, the IMDRF documents up to speed with how some of the implementations have gone.

And really look at issuing entities relevant standards that are already in place and how they can be used. I really wanted to just share that with you because it starts to bring some of the global perspective in terms of individual countries have to put those in place. And Australia will have to do that as well. But that consideration for how things are happening more globally and how we can continue to provide benefits in that area.

I'd like to also give a bit of an update now on our early adopter projects. The Queensland health project, we're continuing to scope the selection of hospitals and devices for that. That work is continuing. We're continuing discussions with another jurisdiction for a potential second early adopter project so that will be possibly two we'll have up and running in a short time frame. And we're also having ongoing discussions with software developers, with registries, with a whole range of those organisations who need to adopt and use the UDI to get the benefits.

Again from that early adopter process but also to try to accelerate the use of UDI in those systems going forward. We've had around four of our triggers working group meetings already and they are co-chaired by Dennis Black from Becton Dickinson and Dr Oliver Daly who is a practising obstetrician urogynaecologist and also part of registry work that's happening in Australia. We have between 25 and 30 organisations and people involved across a broad range from manufacturers to hospitals to issuing agencies.

We've really looked at an Australian and a global perspective and all of our participants have been sharing information around experience from U.S. or for other organisational implementations for example, different lenses. And there's been some aha moments from an Australian perspective to say, okay now I get what that means for Australia is this in terms of triggers. So it's been really useful to bring Australian manufacturers and organisations up to speed by particularly leveraging what we can and have learned from the U.S., which is really important.

In terms of what we're doing for next steps, we're preparing for a regulatory consultation early next year. That work is underway. We're continuing to work to connect a beta version of the National Product Catalogue, or if you're overseas it's called the Global Data Synchronisation Network, with our sandpit UDI database. And we're continuing to develop that functionality and test that with user groups as we develop it so that's an ongoing process.

We've also now finished our internal user acceptance testing on the changes to incorporate the GMDN nomenclature code changes, the Global Medical Device Nomenclature changes into our existing systems on a daily basis. So that should relieve some of the challenges from a sponsor perspective around registering devices where some of that information might not have been in our Australian system.

I want to go through and cover some of the questions and answers that we didn't have a conversation around last time. If you remember from our last webinar I said we've had over 150 questions and we've got some key themes that are emerging. And they're basically around implementation timing and we did go through that in the last webinar in September. International alignment which as you can see continues to be a focus. The scope of devices included. The alignment with our Australian Register of Therapeutic Goods, that's our existing dataset and our existing TGA processes.

Rachel

The Australian UDI database and the data provision to that. The Global Medical Device Nomenclature. Generation of UDIs and issuing agencies. And over the past two months you will have got the GS1 background and today the HIBCC background as well to start to inform some of that conversation. Labelling. The use in clinical systems and patient records. And the collaboration and engagement processes. So I talked a little bit about some of those in the last webinar but today I want to continue with the ones we didn't get time for in September.

And one of those is the Global Medical Device Nomenclature. We've had a number of questions around the relationship between that and UDI and how that's going to work. So what we do know is that the GMDN will be one of the data elements that will be required to be provided with the device UDI data. And it won't be replaced by the UDI. We'll keep those. Each model of device will require both a UDI and a GMDN code and currently if there are no changes to the characteristics of a device the GMDN is valid for the life of the device even if the GMDN agency amends that code or makes it obsolete.

As part of the Australian Register of Therapeutic Goods, our ARTG clean up that we're going through there's no plan to force sponsors to lodge change requests in relation to those changes and there's no current plan to change the way GMDN codes are implemented for Australian in vitro diagnostic devices. We still do need to do some work so we're still exploring the benefits in potentially also collecting the European Medical Device Nomenclature, the EMDN that is mandatory in the EU which doesn't collect the GMDN for example.

We're still looking at potential processes for making changes to the GMDN over time because that is something we're exploring. And the relationship overall between the ARTG and the UDI database for GMDN is something we need to look at as well. In terms of generating the device identifiers and issuing agencies so we've had a number of questions around this and what the Australian framework might look like. So we know that issuing agencies are responsible for generating UDIs according to international standards.

And Australia is planning to adopt or accept UDIs created by GS1, HIBCC and the International Council for Commonality in Blood Banking Automation, including where those have already been applied to devices in the EU and the U.S.. And that's around really recognising Australia in that global market but also reducing the regulatory burden for manufacturers who are already providing to those markets. The manufacturer is responsible for obtaining UDIs and allocating them to devices.

You heard from Allison's presentation that in other countries they might be called labelling and that there are relationships there that we need to take into account. We will do that as part of what we're doing. From Australia's perspective while we haven't yet defined our position on the issuing agency framework, whether it will be an accreditation model, how that will work, we do recognise there are already three that are generally used in a number of countries including the EU and the U.S.. So that's part of our consideration there.

We've had a number of questions around labelling and so we know that we, as I just mentioned, we are planning to accept UDIs created by GS1 and HIBCC and ICCBBA, including where they've been applied to devices in the EU and the U.S.. But some of the questions we still need to explore are around whether the implementation of UDI barcodes into product labels will be considered as substantial change in terms of our existing regulatory framework.

And if there's a requirement for a conformity assessment review or will this be assessed at the next surveillance audit. So that's something that we're still considering and we'll need to provide an update on. Also considerations for small products. So if you think about products that are too small perhaps to have a full UDI and PI information on there what might be our specific requirements. And so some of those endodontic small devices have been given as examples of where we might need to consider that. So that is something that we are still looking into and need to provide information on.

And then we also need to look at sort of a bit more about their use in clinical systems and patient records and that's some of the questions we've had already. How do we start to use the device identifier to link to patient information? So, we're not collecting any patient information or any linking between devices and patients in the TGA's database, the Australian UDI database, but in order for those benefits around matching and traceability back to patients and implantation and use, obviously that needs to be recorded in those systems.

So, it's outside the scope of our project but we are still working with early adopters to look at what we might need to incorporate, or guidance, or what we might need to consider in our implementation through that early adopter use. And as I mentioned we're talking to a number of registries and we're looking at those devices from a Queensland early adopter process, and our second early adopter project to feed that into registries to start to understand what that looks like and if we need to make any changes or consider anything we haven't yet looked at.

We continue with all our collaboration and engagement so as I said we have our first working group that is up and running. If we have anyone who's interested in proposing a topic or a guest speaker for our webinars, being involved in any way please use our UDI email address which is udi@health.gov.au and provide that to us there.

MVW

Thank you so much Rachel. We do only have one question at the moment so if there's anything that you'd like us to cover we have a few minutes left. We'll finish early if we don't receive any more but if there's something specifically, you'd like us to cover today then please feel free to send that through. We did get a question on which version of the GMDN agency code set we're using for the Global Medical Device Nomenclature, and what we're doing at the moment is we're using daily updates to add the new codes into our Australian Register of Therapeutic Good.

The GMDN Agency provides a monthly update of code changes and new codes and also a daily change set. Right now we are using the daily updates.

So that means that apart from the time it takes to get the Agency code set and load it into our systems we should be one to two days behind the GMDN Agency code set in the worst case.

Our plans for UDI are also to have that time frame, to have daily updates where possible so again at the most we're approximately a day behind the GMDN Agency in any of those changes. And so what that means is as a manufacturer if you need a new code created by the Agency then once that's done the TGA will have those very quickly after those changes have been made in the code set. Hopefully that answers that question.

Another question which is, can we have a chance to participate in the workshops? Yes, the current workshops and working groups we have in place, we just have that one for triggers at the moment, so working around the different views around what the impact of changes to UDIs have through the health system, through manufacturers, through registries, for example, to provide recommendations and put some scenarios together for us to consider in our regulatory framework which will then need to be approved by government.

But yes please, if you'd like to be a participant in one of our working groups, perhaps provide us with feedback on our technical build around our database, have a discussion around some of our regulatory framework that we need to continue our work on ahead of that consultation next year, please let us know through our UDI email address, udi@health.gov.au And what we do is we keep a list of everyone that responds to us through there and as we create these we go out to that group requesting input or participation as needed.

So please, yes, appreciate anyone who'd like to be involved. It's really important that as we continue with the build and the design that we get those aspects and that feedback to what we're doing. So really appreciate everyone's time to do that and welcome it. It's something where we need to do this together to make sure that we get it right.

I have another question. What is the expected date for UDI requirements in Australia? In our last webinar in September we published the four key dates. And so our anticipated dates are that by June next year, so June 2022 we'll have a sandpit version of our technical system to enable organisations to start to connect up, to hook up to see what that might look like. That will be not a production version but a place where everyone can test the connectivity around and have a look at it.

Then by June 2023 we need the regulations finalised to give us 12 months to give industry. We've heard that industry needs 12 months to prepare systems, to do all the work that's required. And so the regulatory framework we will complete by 2023, June, which gives us our first mandatory compliance date of June 2024. What we've said is that we plan to have our full production technical system and the database and the data collection provision, the publicly available download of the data, ready at the end of 2023.

So we're looking at some voluntary compliance ahead of the mandatory compliance dates. And the reason we're doing that is because we got feedback from our second consultation that we could potentially accelerate and go faster.

So we're looking at ways we might do that particularly around utilising some of the data from the U.S. global UDI database that's publicly available. But also making the system available as early as we can for voluntary compliance across all devices for example.

One of the questions is, when you say you are considering your position on the issuing agency do you mean that you may consider being an issuing agency also? That's a really, really good question and we know some other countries have already done that, so it is part of our considerations. We don't have a response on that yet but we need to look at what our framework looks like across all, so any external organisations. But also then from a TGA perspective, do we have a scenario where we might consider that we also would need to be an issuing agency. So really good question. Thank you.

So I've got one more question and we've got three minutes so we'll make this the last one. Thanks to everybody for sending all those questions in. So, the last question is, what will be the topic of the January consultation paper? We said the consultation will be quarter one, quarter two next year, but the plan will be that that will be around the regulatory framework. So less around some of those technical aspects around machine to machine or data provision, but really around what should the regulatory framework look like in terms of labelling requirements, data elements that are mandatory, data elements that we'll collect that are optional for example.

All of those things but we'll also then start to look at how UDI starts to become part of our regulatory framework outside just our collection of our database. So how is it going to be required and provided around recalls, around adverse events? All of those other areas that it is key to providing that traceability to, we need to start to incorporate into our other systems and regulatory framework more broadly, so that consultation will be around the regulatory aspects. Thanks for that question, really good question.

We're pretty much right on time so I want to thank again Allison for making the time to come and present to us today. I really appreciate it. If there's any questions for Allison that you still might have please send those through to us and we'll make sure they get to her and will provide an answer, so really appreciate that.

Thank you for everyone participating today. If you have any ideas about how you might want a guest speaker at our other webinars, or topics you'd like us to cover please also send those through. We really appreciate your feedback on getting these right. We're right on time, thanks again everybody, thanks Allison, and we'll see you all the third Tuesday in November, same time. Thank you.