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Webinar presentation: Application for consent to import, supply, or export a medical device non-compliant with the Essential Principles

18 November 2021

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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: Amanda Craig, Devices Post Market Reforms and Reviews, Medical Device Surveillance Branch
  • Presented at: Online webinar
  • Presentation date: Tuesday 19 October 2021
  • Presentation summary: : Guiding you through the new online form to request TGA approval to supply non-compliant patient information materials.

Recording of online webinar

Transcript

Speaker Key

AC - Amanda Craig

KF - Kathryn Fuller


AC

Before I start, I would like to acknowledge the traditional custodians of the land on which we all meet today, wherever you are situated, and pay my respects to their elders past and present. I extend that respect to Aboriginal and Torres Strait Islander people here with us today on this webinar. Thank you for joining us today to discuss the application process for consent to import, supply or export medical devices that are non-compliant with the essential principles.

As this is a bit of a mouthful, from here on, I'll just refer to this as the consent to supply form. The TGA is modernising this process to move from a standalone paper-based form to an online form, which is integrated with your TGA electronic business systems account or eBS, as we like to call it. And also it will integrate with the EPA post-market compliance system. The transition will occur in two phases, with the first phase being an interim online form, which is now complete and ready to use, and will be described in this webinar.

In this first phase, we have built two interim forms which are hosted on the TGA consultation hub. One of the forms is the general application form for consent to supply medical devices that are non-compliant with any or multiple essential principles. And the other form is specifically if the consent to supply relates to non-compliance with essential principle 13A, which relates to patient information materials.

And today, I'll be guiding you through this specific form for patient information materials. There will be another webinar tomorrow, Wednesday 20th October, from 12:30 to 1:30, to walk through the general application for consent form for devices which are non-compliant with essential principles other than or in addition to essential principle 13A. Today's webinar will be divided into two parts. The presentation will take approximately 40 minutes and the rest of the time will be dedicated to a question and answer session.

The topics covered by the webinar today will be a brief introduction on why and when you need to apply for consent to supply, how and where to apply for consent, what the new form for non-compliant medical information material looks like. What the TGA expectations are in regard to the information that you will need to provide. And then I'll touch on the process after you submit the application form, including the payment of fees.

Then there'll be an opportunity for you to ask any questions that you may have. Please type your questions at any time during the presentation, as Rachel mentioned, into that message box, that Q&A box at the bottom right, perhaps, of your screen. And we'll try to answer as many as possible during the second part of the webinar. If we can't get to your answer, though, in the time allocated and we may need to come back to you then.

If you want us to do that, please ensure that you add your contact details when you post the question to us if you'd like us to respond to you later. Let's begin with the background. The reason that you need to apply for a consent to import, supply or export medical devices that are non-compliant with the essential principles is because that there are criminal offences under section 41MA and civil penalties under 41MAA of the Therapeutic Goods Act if you supply non-compliant medical devices.

Unless consent has been granted by the secretary of the Department of Health. Whilst the TGA expects and requires compliance with the essential principles, there may be some extenuating circumstances preventing compliance to one or more parts of an essential principle for a limited time period. If this is the case, then you can apply for consent to supply the medical devices, even though there are non-compliances.

The TGA will then review the risk of supplying those non-compliant medical devices with consideration to the risk mitigation strategies that you as the sponsor or the manufacturer are going to put in place for this time. It should be noted that if your non-compliant device is currently part of an application to vary the device or the manufacturer’s evidence or you have an application for inclusion in the ARTG and the devices are going to be supplied whilst non-compliant with the essential principles, you will need to apply for consent.

If you are seeking consent to supply for non-compliant devices, there are three steps that an authorised representative of the sponsor needs to do. First, complete and submit the relevant application form, which can be located from the essential principles consent for non-compliance web page. This page will also provide you with a copy of the guidance document on how to complete the application form. You also need to attach all the relevant documentation, which we will go through shortly.

And then finally, you need to pay the applicable processing fees in full. The delegate of the secretary will take all relevant information into consideration when determining whether to grant consent. And notification will then be sent to the sponsor advising of the outcome. Applications relating to non-compliant patient information material are deemed to pose a low risk of harm to patients. And we acknowledge that the non-compliance may be the result of different time periods for implementation of regulatory requirements between Europe and Australia.

Therefore, we envisage that the processing time for these particular kinds of applications will be rapid. And the TGA will focus on ensuring compliance with the implementation plan post-consent. Let me start with the application form. Whilst the TGA is building the new integrated solution, we have developed an online interim application form to hopefully make application for consent easier and more streamlined.

And this interim form is published on the TGA consultation hub. This particular application form can only be used for devices that are non-compliant with essential principle 13A, which is the patient information material. And need to have the same implementation plan and proposed consent dates. If the application for consent relates to additional essential principles, then you'll need to complete the general consent application form, which is also located on the TGA consultation hub.

An application can be submitted for entries currently included in the ARTG or for applications for inclusion. If the same implementation plan and proposed consent dates are applicable to the ARTG entries and the applications for inclusion, then they can all be included in the same consent application form. Each consent application form can accommodate up to 100 ARTG entries or/and 100 applications for inclusion within the form.

Or if you have more than 100 ARTG entries or 100 applications for inclusion that relate to the same implementation plan and dates, then we also have the facility that you can upload an Excel spreadsheet with a list of all the entries. And I'll describe this in a little more detail in the following slides. You can also complete multiple forms if you have different implementation plans or dates. And then you can submit them at the same time to have those multiple forms considered as one application for the purpose of processing and fees.

Which, again, we'll go into a little more detail. The first page that you will see in this interim form is the overview page. This page provides you with the backgrounds that we've just spoken of and the information relating to fees for the application, which we'll cover shortly. There are also links on this page to the guidance document and the medical device regulations.

At the bottom of the overview page, you can click on the application for consent to import, supply or export a medical device that does not apply with the essential principles related to patient information material link. And that will start your application. This will take you to the contents page. The contents page links you to all the different sections or pages in the application form that you're required to complete as part of the application.

When you complete each page, you'll be returned to the contents page where you can select the next page to complete. To start, click on the applicant detail link. There we go. The first page requires information about the applicant, including the name of the person submitting the form. The TGA expects that only authorised representatives of the sponsor will be completing the form… Sorry, it’ll only be an authorised representative of the sponsor completing the application consent form.

You'll need to include your TGA electronic business system, tBS, client ID number. You will also need to include your email address. This email address will be used to send a receipt and a PDF copy of your application once it's submitted. There are radio buttons to select whether you're the sponsor, the manufacturer or the agent. Please select the option that best describes your role in relation to this application for consent that's being submitted, as you can only select one option.

If you're a manufacturer and a sponsor, then the most appropriate would be the sponsor in this case. The sponsor details are also required. Next, you need to select whether the consent relates to import, export or supply. And you can select all of those or just one of those. You're also required to provide the total number of ARTG entries and/or applications for inclusion in the ARTG that will be included in this application for consent, remembering that you can have multiple application forms submitted at once.

Next, you are asked if you are submitting more than one form. As mentioned previously, if you're submitting different implementation plans for different ARTG entries and applications for inclusion, then you'll need to submit separate forms. If this is your first form, even if you’ll submit multiple forms, then you select no here. If this is your second or subsequent form as part of the application, then you just need to submit yes.

And then provide the application IDs for the other forms submitted so far so that we can link all of these for the purposes of processing and fees. We do ask that you have these multiple forms submitted within 24 hours if you want them to be considered as a single application. And this is due to the way that those fees will be applied. Once you've completed this information, you can either press save and come back later to complete the rest of the application at another time.

Or you can press continue to keep filling out the application. If you select save and come back later, you will be sent an email with a link to return to the application form. If you select continue, you’ll be returned to that contents page where you can select the link for the next page, which is information on non-compliance, to continue this application. This section of the form contains mandatory fields for information also, but on the non-compliance to the essential principles.

Here, you'll need to select the relevant part of essential principle 13A that the devices are non-compliant with. You can select more than one part of essential principle 13A, but you cannot select other essential principles. If your application for consent does not relate to non-compliance of 13A solely and the devices are non-compliant with other essential principles, you will need to complete the general application form for consent.

Next, you'll need to describe how the devices do not conform with those selected parts of essential principle 13A. For example, if the patient implant card does not contain the model of the device, this should be specified in that free text box. Rather than just stating that the patient card is non-compliant with 13A, please state that it's the model that's missing from the patient implant cards. Next, you need to provide the proposed duration for the consent to supply.

Here, you’ll need to select your proposed start date and the end date for consent and include a reason in the text box as to why those dates have been selected. For example, if you're selecting the devices that are non-compliant with patient information cards or leaflets, due to the manufacturer implementing changes in line with the European regulations, then you may choose your start date as 1st December 2021 and the end date as 25th May 2024.

And state that this is due to the manufacturer aligning with the European regulations. You will also need to provide a strategy to mitigate the risk associated with the non-conformance for all the ARTG entries and applications for inclusion. The strategy for mitigating the non-compliance can be provided here as free text or by uploading documents or a combination of both. If you're only uploading a document, then in that free text box, can you please identify the name of the uploaded document that relates to the mitigation strategy?

Especially if you're uploading multiple documents. Just guide us through those documents that you're uploading. Documents uploaded should include an implementation plan that includes information such as the proposed risk mitigation strategy and how it will be implemented and when that mitigation will commence. For example, if the consent application relates to non-compliant patient implant cards due to missing device information, it will be expected that the implementation plan would include what information is missing from the card.

That is, the plan may state the card is missing the device model and the batch number. The implementation plan will also need to describe how that missing information is going to be provided to the patient or healthcare facility and when this will be provided. For example, the plan may state that stickers will be provided with the device that can be adhered to the card. If this is the case, the implementation plan will need to include how the non-compliant card is going to be provided to the patient or the healthcare facility.

And when this will be provided. For example, the plan may state that a template card will be provided in bulk prior to the device being supplied. And that extra cards can be requested from the sponsor or downloaded from the manufacturer’s website. The implementation plan should also include what the expectation is of the healthcare facility, if any, to facilitate that convergence of the missing information with the non-compliant card.

For example, the plan may state that the healthcare facility will need to adhere the device’s sticker to the template card. The plan should also inform if there will be education sessions provided to the healthcare facility or patient. And if so, when these will be provided. For example, the plan may explain that the sponsor will provide support to healthcare facilities when products are ordered or supplied.

And the implementation plan should cover when healthcare facilities or patients can expect that products manufactured or when the change will come, that the compliant implant card will come into play. For example, the plan may state that the compliant cards will be introduced for products from 20th May 2022. And healthcare facilities will be advised by email when the new cards are being introduced.

And they'll no longer be required to add those stickers to the template cards. When you're thinking about your implementation plan, think about how the TGA is going to be able to respond to a patient when they contact the TGA to ask about their patient implant card if they haven't received one. And where could they find it? And what could they be expecting? There are also fields to upload an interim non-compliant patient information card or leaflet to support the information that you've provided in that implementation plan, if that's relevant.

Such as a copy of that template patient implant card or a screenshot of the web page for the patient information material, assisting the TGA if we do need to provide further information to the patient or the healthcare facility. The documents and the information provided should relate to all of the ARTG entries and applications for inclusion included in this particular application for consent.

If some of the ARTG entries or applications for inclusion have different implementation plans or different interim PICs or PILs, patient implant cards or patient information leaflets, or different proposed consent dates, you must submit separate consent application forms for those devices. And also please ensure that any documents that you upload are either in Adobe PDF, Microsoft Word or Excel formats.

The last part of this page is where you can provide those Excel spreadsheets of the affected ARTG entries or applications for inclusion if you don't want to enter all the numbers manually on the next pages. There are two separate fields for uploading an Excel spreadsheet with the ARTG numbers and an Excel spreadsheet with a list of applications for inclusion. These are non-mandatory fields because you can upload or put the numbers in manually on the next pages.

The list in the Excel spreadsheet should contain only one ARTG entry or application in each individual cell in a single column, working down the rows. Please do not enter more than one ARTG entry or application for inclusion number in a single cell or across multiple columns. And please do not repeat the ARTG numbers or application for inclusion numbers down that column either. If you have added any extra information relating to the ARTG entry or application for inclusions, please don't enter it into these Excel spreadsheets.

But upload them as separate documents in the previous information in the implementation plan. Once you've completed this information, you can either press save and come back later to complete the rest of the application at another time or you can press continue to keep filling out the application. If you select continue, you'll be returned to the contents page where you can select the link for the ARTG entries for which consent is requested.

Or you can select application for inclusion for which consent is requested, depending if the non-compliant device is in the ARTG or within an application for inclusion. The next page is where the ARTG entry numbers can be provided. On this page, you can manually enter ARTG entries that are to be included in this consent application. This page has 100 fields for ARTG entries. If you have more than 100 ARTG entries that require consent for non-compliance with EP 13A, you'll need to complete an additional form.

Or as we mentioned, you can just upload an Excel spreadsheet with a list of all the affected ARTG numbers. If your application for consent is only for devices that are part of an application for inclusion in the ARTG, you do not need to complete this part of the form. The application for inclusion page is the next page that is within this application form and it is similar to the ARTG entry page. On this page, you can manually enter the application for inclusion numbers that are to be included in the consent application.

Similarly, this page has 100 fields for applications for inclusion numbers. And again, if you have more than 100 application for inclusions that require consent for non-compliance with EP 13A, you'll need to complete an additional form or upload that Excel spreadsheet with a list of all the affected application for inclusion numbers. As with all the other pages, once complete, you can press the save and come back later to complete the rest of the application form at another time.

Or you can press continue and select the declarations and acknowledgments from the contents page. On the declarations and acknowledgments page, all the fields are mandatory. At the bottom of the page after you read through all of that text, you can check the yes box to approve the declarations and acknowledgments, which are in the text above. Enter your name and date in the spaces provided. Once you've completed that information, as with all the other pages, you can press save and come back later to complete the rest of the application at another time.

Or you can press the continue to continue filling out the application. Selecting continue will take you to the contents page where you can select finish, located at the bottom of the page, to submit your application. After you select finish, you'll be directed to an almost done page. On this page, you can select submit response to submit the application. Or if you've had a moment to think about this, you can also select back to amend the application.

Selecting back will take you to the contents page. After you submit the application, an acknowledgement email will be sent to your nominated email address, which you completed back on your first page, with a copy of this submission. And this will include that response ID number with this application form. And that's the number that you need if you want to submit multiple forms. Please ensure that you keep a record of this response ID for any future correspondence that you need to have with the TGA.

Once you've submitted the application form, you’ll need to pay the application fees. Applications for consent cannot be processed until all applicable fees have been paid in full. The current fees for application for consent to supply apply to each ARTG entry and application for inclusion included in the application. The fees are $500 currently for the first ARTG entry or application for inclusion and then $100 for each subsequent ARTG entry or application for inclusion in the application for consent.

For example, if your application for consent has 220 ARTG entries, $500 is applied to the first ARTG entry and then $100 to each of the remaining 219 ARTG entries, which equates to the application for consent costing $22,400. As consent to supply non-compliant patient information materials has a different risk profile assessment and follow-up when compared to consent applications relating to other essential principles, the TGA has proposed to government to amend the current regulations to have the fee for applications for consent that only relate to EP 13A.

To have that change to be a flat fee of $30 for each ARTG entry or application for inclusion. This means that an application for a consent for non-compliance with essential principle 13A, where there are 220 ARTG entries, the total cost will be $6,600. The TGA has also proposed that this fee reduction be applied retrospectively to applications for consent as far back as 1st January 2021. If this proposal is accepted, there will be a refund of fees applied to those applications that have been processed already relating to essential principle 13A only.

It is expected that a decision will be available early November on the proposed amendments. If you are submitting multiple forms due to having more than 100 ARTG entries or applications for inclusion or you have applications with different implementation plans, please submit all of those forms within 24 hours to avoid that initial $500 fee for the first ARTG entry being applied to subsequent applications for consent.

There are two ways that you can pay the applicable processing fees. You can pay that by immediate payment. In this case, you have to calculate the total fees, pay immediately after completing and submitting the application. Or you can have a payment against invoice. If you require the TGA to raise an invoice for payment, simply complete and submit the application for consent and the TGA will raise and send the submitter an invoice for the processing of fees.

If you do wish to make an immediate payment, as mentioned, you'll need to calculate those total fees for your application based on the number of ARTG entries or applications for inclusion in line with the current fees being $500 for the first ARTG entry, plus $100 for each of the remaining ARTG entries as described previously. You then go to the TGA payment page. And in the Biller Code, you choose option nine, which is exemption under S41MA device.

You enter your client ID number in the box provided. You can then enter one ARTG or application for inclusion number from your application in the invoice number box provided. It is preferable so that we can match this invoice payment up with your application that you just choose your first number that was in the list of ARTG entries or applications for inclusion. You then enter the total amount of fees to be paid in Australian dollars, select the payment method and then follow the instructions to complete the credit card payment.

If you choose this payment option and you're submitting those multiple forms, please ensure that you only pay the fees after the submission of your final form in the application. If you pay the fees prior to the submission of the final form in your application, any subsequent forms may be charged as a new application. Once the fees have been paid, the post-market team will receive the application.

If there has been insufficient information provided in your application or you've missed uploading the documents, we will email you for you to provide that missing information to us. To ensure that supply of medical devices are not adversely affected, especially if we receive a large volume of applications for consent, you may receive consent to supply prior to the detailed assessment of the implementation plan.

As a result, you may be required to provide additional information after that consent has been granted. An email with the consent to supply decision notification will be sent to you to inform you of the decision. During the period of approved non-compliance, you may be required to demonstrate that you are following the approved implementation plan. We may ask you for a copy of the patient implant card or a link to your patient information leaflet.

Or we may ask you if you've had any issues with the way that the implementation plan is being progressed. Please be aware that consent can be withdrawn at any time if there is non-compliance with the approved implementation plan or if the implementation plan is audited and is deemed insufficient to mitigate the non-compliance. If there are any concerns, however, regarding the implementation plan, you will be provided with an opportunity to amend the plan and address any concerns that we have.

At the end of the consent period, you will be required to submit evidence of non-compliance or that you are now compliant with essential principle 13A. As mentioned earlier, this is the first stage of the modernisation of the consent to supply process. We’ll keep you updated with further information as the integrated solution is implemented.

It is anticipated that the integrated solution will occur in a couple of stages also so that we can expedite the functional components to users, rather than waiting for that entire project to be completed before deployment. The next stage of the modernisation programme is to have the form available to you from your login through eBS, eBS being the electronic business system. This is scheduled for the beginning of 2022, but we are always hopeful for an earlier release.

This means that your details will prefill the form when you begin an application for consent and you'll be able to select your ARTG entries from a list. The information will then be submitted directly into the post-market database where we'll be able to push limited notifications to you through the sponsor compliance dashboard. The next phase will be to be integrating those applications for inclusion through the e-form in eBS, electronic business system also.

As well as integrating directly with the billing services for your invoicing and payment. In addition, the notifications that can be sent and the submissions received through that post-market compliance dashboard for sponsors will also be increased. This means that when you need to provide evidence of compliance at the end of the consent period, this can be done simply by submitting your non-compliant or your now compliant documents through that sponsor dashboard.

It is anticipated that this will be completed by about mid-2022. During this process, we will provide similar email updates, web updates and webinars to provide you with that context of how this project has progressed.

KF

My name’s KFtherine, for everyone in the webinar. I work with Amanda. And I'm just going to read through some of the questions that have been coming through as we've been listening to the presentation. The first lot of questions are coming in around timelines for processing the application. What is the expected timeline for reviewing the applications for consent? How far in advance should sponsors be submitting these to the TGA to ensure that they can continue to supply their devices from 1st December?

AC

That’s a really important question. We are looking to do a really rapid turnaround on those applications coming in. As soon as you can get your applications in and we can review them, we think that everything will go out almost instantaneously to you. And we'll focus more on that post-market component of looking at those implementation plans. But saying that, it's always helpful if you don't submit them the week before 1st December when you need consent.

As early as possible to get them in. But a week would be great if we could have at least that time. Being mindful as well that we can't actually process those applications until the payment has been made. Give yourself enough time to make sure that you can have that invoice paid as well.

KF

We've got some questions around where this is applicable. One of them is, will this provision be applicable to device applications submitted before 1 December, the devices that are then listed in the ARTG post 1 December?

AC

Yes, absolutely. If you know that your application or your devices that are currently within an application for inclusion will not have compliant patient information material, you will need to request consent for that. You can apply for consent at any time that you have that application for inclusion with our post-market team.

KF

Another question here. How does the TGA plan on verifying the implementation plans are appropriate and actually being carried out?

AC

We'll review the implementation plans and see whether all of the information that really needs to be there has been provided in some way or another. Of course, patients and healthcare facilities often contact us to let us know that perhaps they don't have a patient implant card for a particular device or they're not able to provide patient information material to a patient. That is one of the easy ways to know that it's not going to plan.

Whilst we may ask for copies of things, we also have reports that come in frequently from patients or healthcare facilities.

KF

Just had a couple of questions in around the start and finish of the proposed consent period, specifically around, what is the maximum time in terms… You mentioned around 25th May to be in line with the EU MDR changes. But what if they wanted to apply for consent to be post the 25th? Can it be five years? Could it even just be May 26th, for example?

AC

We would expect that there would be some good justification for being non-compliant for such a long time. It will be expected that if this was due to becoming compliant with the European regulations, that that time period wouldn't go much beyond 2024. We would need some justification as to why that is going beyond 2024. But definitely consent, we can grant consent for several years.

KF

A lot of our questions are coming in around what is considered compliant in regards to PICs in particular. I'm going to ask some questions about that. But before we get to that, a question has come in around, are we required to submit newly created PICs and PILs to the TGA for assessment? And if yes, what option does the TGA have for submitting these things? I'm assuming this is around compliant PICs at the end. It’s how I read it.

AC

If you are a sponsor or a manufacturer of an implantable medical device and you have a compliant PIC or PIL, a patient implant card or patient information leaflet, and that device is already being supplied in Australia, it's included in the register already, the TGA does not require to see that patient implant card or information leaflet. We may ask to see it as part of an investigation if there's an adverse event report or part of a post-market review.

But you do not need to submit your implant cards and leaflets if they are compliant to the TGA. If at the end of consent to supply, because you've now gone from a non-compliant patient implant card and leaflet to a compliant patient implant card and patient implant leaflet, you'll be able to submit a copy of those compliant patient materials through the sponsor dashboard. And as that consent to supply period finishes, we'll provide extra information on how to provide those to us.

KF

A number of questions in regards to PICs, as I mentioned. Let's talk about PICs. One of the questions… And we had a few questions. In cases where a physical patient implant card is provided containing the manufacturer's information with the device… The card is with the device. And a sticker containing the device information is also provided with the device. But the sticker is required to be adhered to the card at the point of care. Is this considered compliant with the legislation?

AC

Yes. The legislation says that a patient implant card must be provided. And it then lists information that has to be provided with the device. As the patient implant card and the sticker provide all the information that's required, all the requirements of patient implant cards, and they're both provided with the device, then that is considered compliant with the legislative requirements.

If, however, you're providing the patient implant card to the healthcare facility and the sticker just within the device, then that will need a consent to supply because both are not being provided with the device, as the legislation currently stands.

KF

Just to confirm, I've had another question just in regards to so. If the PIC or the PIL are not provided pacKFged up with the device, i.e., they're provided by the sponsor at the time or before, at the point of care and supply to customer, is that considered compliant or not? Not with the device.

AC

The current legislation is clear that it has to be with the device. However, along with our legislative changes that we're proposing to government on the fees, we are also proposing slight word changes around with the device. Early November, we may see that if a patient information leaflet is provided electronically, and that is not with the device, then that would be compliant. But we will be able to inform everyone more after we receive that feedback from government whether the regulations can be amended.

KF

Couple of questions around haemostatic agents. Does the TGA still intend to require sealants and haemostatic agents to be supplied with PICs and PILs, even though these products are normally reabsorbed over a six-month period?

AC

Currently, the guidance has these kinds of devices as not exempt from the requirements. However, similar to change of dates, our fees and the term with the device, we are also looking at amendments to some of those exempt devices. As this information becomes available, we'll be able to provide this also. But again, we're looking at that government decision around the beginning of November on our proposed amendments.

KF

Got a question here. Does this apply to implantable devices that have been imported into Australia in the last year, but not yet sent to hospitals?

AC

This is a good question because this talks about supply. If it's come in to the sponsor, but the sponsor has not supplied it to the customer, then it has not been supplied. And therefore, you will need to have a compliant PIC or PIL, patient implant card or patient information leaflet, with that device. You will need a consent if you have a small batch of devices that are going to be non-compliant.

KF

I've got another one here. With regards to consignment stock that was supplied prior to 1 December, if the stock do not have implant cards, can they be moved from one account to another after 1 December 2021?

AC

If you have implantable medical devices that have been supplied, it has been sent to the healthcare facility, they have taken carriage of that stock and that was before 1 December, it does not require to have a patient implant card or leaflet provided with it. However, if that device comes back under the sponsor and it’s then redeployed out again or resupplied, then that will need a patient implant card or leaflet following 1 December.

KF

Just another couple of questions here in regards to processing. Are we still permitted to use the TGA pro forma for consent to supply or do we need to use this interim online form?

AC

You will need to use the interim online form as the form for consent to supply medical devices.

KF

If we choose to request an invoice, will the invoice be issued to the applicant within 24 hours or will it take longer?

AC

We are ever hopeful that it will be done within 24 hours. This is, of course, all dependent upon how many invoices a billing area has to produce. But normal practice is within that 24 hours.

KF

Got another question here around consent applications for inclusion. If TGA post-market approved consent for an application for inclusion, will post-market inform device application section or will the sponsor need to send the consent approval to the device application section so that it can be considered in the inclusion?

AC

A great question. Often, we look like we are quite siloed. But the post-market team will work very closely with the pre-market team for all of these consents to supply. The delegate of the secretary for consent to supply sits in post-market and we will then inform pre-market when those consent applications have been approved.

KF

Another one, can you apply for consent for PICs only? If the PIL would be available on the due date, a compliant PIL by 1 December, but the PIC not compliant till 2024, can you apply for PIC, not PIL?

AC

Absolutely. And the other way around as well. You can do one, not the other or both.

KF

Just going through some questions that have just come in later. Can the implementation plan not include not supplying a PIC at all as opposed to providing a PIC which is just non-compliant?

AC

No, you will need some information that is going to go to patients. They do need to be able to know those risks associated with the implantable devices. If this is not with the device, but you want to have it up on a website as an electronic version of it, then that is fine.

KF

If an implantable device has a ten-year shelf life and was manufactured in 2020, it may not have the PIC, PIL included with the device. The timeframe for compliance would then be up to nine years after 2024. Would this timeframe be acceptable?

AC

You're saying if a product is manufactured now and has ten years, then you're not going to be compliant? I would expect that there will be some risk mitigation put in place to have these as compliant things in outserts. I'm sure there is some way that the manufacturer will be able to provide a compliant PIC or PIL with the device, if not inside the device, but on the box. I do not think that it will probably be acceptable to be non-compliant for that long.

KF

Another question around PICs. If a sales rep takes the device to the hospital, at the same time, gives the PIC to the user, the sticker is on the device box, would this be considered compliant?

AC

Yes. If it goes with the device, then that is compliant. Whether that's an outsert provided stuck on the outside of the device or whether that is someone physically delivering it with the device, that's great.

KF

Can an IFU be used in lieu of a PIL?

AC

The patient information leaflet requirements are really clear on the readability for the patient. It has to be something that the patient will be able to understand and pull out those risks associated with that so they're able to make informed consent. If your instructions for use document is suitable for a patient to understand and to be able to meet all the requirements that are in the patient information leaflet requirements in the legislation, then it may be appropriate.

I would think something like an orthopaedic device or perhaps a pacemaker may not be appropriate. And IFU for those sorts of devices may not be appropriate for a patient to be reading. You really need to look at the audience for that information leaflet. I think we’re going to wind up.

KF

Yes, we’re going to wind up. We’ve got one more. Do we need to apply for consent if manufacturers plan to release the devices with implant cards and information leaflets from 1 December from the site? I’m assuming if…

AC

You’re great, yes. If you're going to be compliant from 1 December and the manufacturers don't, then that's perfect. However, if you're supplying non-compliant devices, then you will need a consent for those devices that don't have the PIC and PIL. Thank you everyone for joining. And I think we're going to be wound up and shut down now. Thank you so much for your time today.