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Webinar presentation: Webinar 2 Application for consent to import, supply, or export a medical device non-compliant with the Essential Principles

17 November 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: Amanda Craig, Devices Post Market Reforms and Reviews, Medical Device Surveillance Branch
  • Presented at: Online webinar
  • Presentation date: Wednesday 20 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

Amanda Craig

Good morning and afternoon, everyone. My name is Amanda Craig and I'm the director of the devices post-market reforms and reviews section in the medical devices surveillance branch of the Therapeutic Goods Administration. 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 and 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 tBS, eBS, as we like to call it, and the TGA 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.

You can, of course, use this form for essential principle 13A as well. Today, I'll be guiding you through the general consent application form. If you would like more information on the patient-specific form, you will be able to find a link to that recording of that webinar, which was held yesterday, Tuesday 19th October, on our TGA website next week. 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 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 patient information material looks like. What the TGA expectations are in regard to the information you'll need to provide. And then I'll touch on the process after you submit the application form, including the payment of fees.

There will be an opportunity for you to ask questions that you may have. Please type your questions at any time during the presentation into the message box, potentially at your bottom right. And we will try to answer as many as possible during the second part of the webinar. If we can't get to your answer in the time allocated, we may need to come back to you on some questions. Though be sure to include your contact details when you post a question.

Let's begin with the reason why you need to apply for consent to import, supply or export medical devices that are non-compliant with the essential principles. That's because it's a criminal offence under section 41MA. And there are civil penalties under section 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 period of time. 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 review the risk of supplying the non-compliant medical devices with consideration to the risk mitigation strategies that the sponsor or 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 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 still need to apply for consent.

If you are seeking consent for supply of non-compliant devices, an authorised representative of the sponsor needs to complete and submit the relevant application form, which can be located on the essential principles consent for non-compliance web page. This web page also provides you with a copy of the guidance document on how to complete the application form. Secondly, you need to attach all the relevant documentation, such as a risk mitigation strategy or an implementation plan.

And then thirdly, 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. A notification will then be sent to the sponsor advising of the outcome. For those applications that relate to non-compliant patient information materials, these are deemed to pose low risk of harm to patients.

And we acknowledge that non-compliance may be a 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, that is, applications for consent for non-compliance for 13A, will be rapid. And the TGA will focus on ensuring compliance with implementation post-consent.

Let's 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. The interim form is published on the TGA consultation hub. This application form can be used to apply for consent to supply devices that are non-compliant with any or multiple essential principles, including 13A, the patient information material.

Although there's a specific interim form for applications that only relate to essential principle 13A, which is also located on the TGA consultation hub, you can also use this form as well. If the application for consent relates to essential principle 13A as well as other essential principles, then you will need to complete this general consent application form rather than the specific patient information form. Each application form, at these general application forms for consent, can accommodate up to 20 ARTG entries or applications for inclusion within the form.

However, if you have more than 20 ARTG entries or applications for inclusion, you can complete several forms and link them as a single application for the purpose of processing and fees. For example, if you have an application to cover 55 ARTG entries, you can complete three forms entering the ARTG numbers in the boxes provided on the relevant page. The first two forms would have 20 ARTG entries performed.

And the third form would have the remaining 15 entries. These three forms will be considered as one application for the purpose of processing and fees and will be linked during the process using the response ID that is generated for each of the forms. And I will describe this in the following slides. The first page that you'll see in the interim form is this overview page. The page provides you with the backgrounds that we just spoke of and information relating to the fees of an 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 link that says application for consent to import, supply and export a medical device that does not comply with the essential principles, to start your application. And this will then take you to the contents page. The contents page contains links to all the different sections or pages of the application form that you're required to complete as part of the application.

When you complete a page, you'll be returned to this contents page where you can select the next page to complete. To start, you can click on the applicant details link. The first page requires information about the applicant, which includes the name of the person submitting the form. And as I said before, the TGA expects that only authorised representatives of the sponsor will be completing the application form for consent.

You'll need to include your TGA electronic business systems, tBS, client ID number. You'll also need to include your email address. This email address is going to be used to send you a receipt and a PDF copy of the application once it's been submitted. There are then three radio buttons to select whether you're a sponsor or a manufacturer or an agent. Please select the option that best describes your role in relation to the medical devices for which the application for consent is being submitted.

For example, if you're a manufacturer and a sponsor, for the purpose of this application for consent, the most relevant role for you is the sponsor. You can only select one of these options. The sponsor details are also required. Next, you'll need to select whether the consent relates to import, export or supply or you can select all of those, as you can select more than one option. You're also required to provide the total number of ARTG entries or applications for inclusion in the ARTG that will be included in this application for consent.

Whilst I was saying earlier, you can put in multiple forms. If in total, your application for consent is going to cover 55 ARTG entries, then it's 55 that you put in this box, rather than just 20 that are going to be completed in this particular form. Next, you're asked if you're submitting more than one form. As mentioned previously, you have more than 20 ARTG entries or applications, you'll need to submit separate forms.

If this is your first form, even if you'll submit multiple forms, it asks you if there are multiple forms. Then select no, because you won't have an application ID number for the other applications yet. This question is only relevant when you submit your second or subsequent forms. After you submit your first form, you will receive an ID number, which you can then fill into the text box with your subsequent applications.

This is only relevant, of course, when you are submitting multiple forms at the same time. You need to submit your forms within 24 hours of each other if you want them to be considered as a single application. You do not need to complete this if you have previously submitted applications for previous consents and you have already paid that fee. 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 press save and come back later, you'll be sent an email to that email address that you put in earlier with a link to return to the application form. And you can share that link with other people in your organisation if you want them to continue filling out the form. If you select continue, you'll be returned to the contents page where you can select the link information on non-compliance to continue with this application.

Information on non-compliance to the essential principles is the next page that you can fill. And this section of the form contains mandatory fields for information on the non-compliance to the essential principles. Here, you need to select the relevant essential principles that the devices are non-compliant with. And that is a list of essential principles. You can select more than one essential principle or sub-essential principle from the list.

With this in mind, your application should be for devices that are all non-compliant with the same parts of the essential principles. If you have a range of products that are non-compliant with different essential principles, then you'll need to complete separate application for consent forms. And then you need to submit the relevant risk mitigation plans against those different essential principles. Next, you'll need to describe how the devices do not conform with the essential principles.

For example, if you're providing a patient implant card that does not contain just the model of the device, this should be specified in that text box rather than just stating that the patient implant card is non-compliant with essential principle 13A.2. You'll then be asked if there are changes in the regulations which are a contributing factor for the non-compliance to the essential principles. And you're provided with a selection to choose from.

If it's a regulatory change that is impacting the manufacturer's ability to remain compliant, then select the most appropriate regulatory change that is impacting compliance with the essential principles. For example, if your devices have non-compliant patient information cards or patient information leaflets, and that's due to the manufacturer implementing changes in line with the European regulations, then you can select yes, change to EU MD regulations.

Next describes the risks that have been identified due to the non-compliance with the essential principles. On the next page, you'll be asked to provide that risk mitigation strategy that is being proposed to counter these risks. But in this text box, we just want you to identify what those risks are. 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 press continue, you'll be returned to the contents page, where you can select the link ARTG application for inclusion number one, to continue the application. This page is the first of 20 pages that allows you to provide information about an ARTG entry or an application for inclusion that are to be included in the application for consent to supply. Each of the 20 pages needs to be completed for a single ARTG entry or application for inclusion.

What I mean to say is that you can't have two ARTG entries or multiple ARTG entry numbers within the one field. Just a single entry or application for inclusion on each page. If the information that you're providing on this page can be used for subsequent ARTG entries or applications for inclusion, it can be reused without the need to re-enter the information. And we'll touch on that in a couple of slides.

The fields that need to be completed in this page include a button to select whether the first device is an existing ARTG entry or if it's part of an application for inclusion in the ARTG. You then need to provide the relevant identifying number in the next box down. Next, you'll need to provide the proposed duration of the consent to supply. Here, you'll need to select your proposed start date and a date that you want the consent to end.

And include a reason in the text box for why those dates have been selected. For example, if you're seeking consent for devices that are non-compliant with patient implant cards or patient information leaflets, due to the manufacturer implementing changes in line with the European regulations, you may choose to enter your start date as 1st December 2021, as that's when our regulations come into force. And an end date of 25th May 2024, as that's when the EU regulations come into play.

And state that this is due to the manufacturer aligning with the European regulations. There is also a question on batches that will be affected. This is not a mandatory field. However, if your application is for a very limited time and only affects specific batches, it is expected that details on the number of affected batches and details on which batches are affected and why or how they're affected will be provided.

For example, if the manufacturer has changed address and the labelling and the instructions for use have been amended with devices that are going to be supplied from December 2021. But as a sponsor, you have a limited number of devices with the previous labelling and instructions for use with the old address from a few batches. Then you'll be able to provide us with the specific batches that will have to be included in the consent due to the difference in the address, in the instructions for use and on the labelling.

The next box is for the information on the estimated stock levels. There are several components to this question, such as the current stock levels, the future stock levels and the expected date of stock depletion. Again, these are not mandatory fields. And where we see that there'll be a consent application for multiple years, then this probably isn't something that you can provide and therefore is not expected.

However, similar to that affected batch question, if your application is for a very limited time and only affects very specific batches and you are aware of the current stock level and foreseeable stock level, then we expect that you will provide this information. This will also assist the TGA in having a better understanding of that potential risk and that impact on that non-compliance. Next, we ask you to provide information on any additional impacts to Australian consumers if the consent is not approved.

Again, this is not a mandatory field. However, this field provides the opportunity to convey any additional impacts that you're aware of, such as there being no other device available in this kind in the ARTG or perhaps this device is important for a particular patient group. Finally, you are asked to provide information on the strategy that is to be implemented to mitigate any potential risks with the non-compliance with the essential principles.

The strategy for mitigating the non-compliance can be provided here as free text or by uploading the documents. If you are only uploading a document, then in that free text box, can you please identify the name of the uploaded documents that relates to the mitigation strategy to help guide us through your application? Documents uploaded should be an implementation plan that includes information, such as the proposed risk mitigation strategy, how it will be implemented and when the mitigation will commence.

For example, if the consent application relates to non-compliant patient implant cards, due to that missing device information, it will be expected that the implementation plan would include what information is missing from the card. For example, the plan may state that the card is missing the device model and the batch number. The implementation plan will need to describe how the missing information 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 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 will be provided to the patient and healthcare facility and when this will be provided. For example, the plan may state that the template card will be provided in bulk prior to the device being supplied or after the device has been 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 the convergence of the missing information with the non-compliant cards. For example, the plan may state that the healthcare facility will need to adhere the device sticker on the template cards.

The plan should also inform if there will be education sessions provided to the healthcare facility or the patient. And if so, when will these be provided? For example, the plan may explain that the sponsor will provide support to healthcare facilities when products are ordered or supplied. The implementation plan should cover when the healthcare facility or patient can expect to receive compliant patient implant cards and how this change will be relayed.

For example, your plan may state that the compliant cards will be introduced for products manufactured from 20th May 2022. And that healthcare facilities will be advised by email when the new cards are being included with the device and they are no longer required to add stickers to template cards.

If you are applying for consent to supply medical devices that are non-compliant with essential principle 13A, relating to patient information material, there are also fields to upload your interim non-compliant patient information to support the information that you're providing in the implementation plan, if that's relevant. Such as you can provide a copy of that template implant card or perhaps a screenshot of the web page for the patient information leaflet.

When you are drafting the implementation plan, especially for patient information material, please consider the information that the TGA will need when patients or healthcare providers contact us to ask us where they can find that information, as that is a regular occurrence. Please also ensure that any documents you upload are either in Adobe PDF, Microsoft Word or Excel format.

Once you've completed this information, you've guessed it, you can either press save and come back later to complete the rest of your application another time or you can press continue to keep filling out the application. As expected, selecting continue will take you to the contents page where if you do not have any further ARTG entries or applications for inclusion to include in this application for consent, you can select declarations and acknowledgement from the contents page to finalise and submit your application.

If you have additional ARTG entries or applications for inclusion to include in this application for consent, you can select the link for ARTG application for inclusion number two page and to continue the application. And details with the next medical device can be entered then. The pages for the remainder of the ARTG entries and applications for inclusion have identical fields as the first ARTG entry application for inclusion page, as I mentioned before.

However, as some of the information may be the same that you've already provided, instead of replicating that information, you can select a previous ARTG entry or application for inclusion from the drop-down options to prepopulate that data. There is also an option to select new information to be entered if only some of the fields can be replicated from the data in previous ARTG entries or applications for inclusions.

If new information is selected, then you'll need to respond to those questions. Once you've completed this information, you can continue with pressing 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 a relevant page to respond.

Once all of that information is completed for all of the relevant ARTG entries and applications for inclusion, then you can proceed to the declarations and acknowledgements page. All of the fields on this page are mandatory. At the bottom of this page, after you've read the important declarations and acknowledgments, check the yes box to approve the declarations and acknowledgments.

Enter your name and the date in the spaces provided. Once you've completed this information, you can then press save and come back later to complete the rest of the application another time or you can press continue to keep 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 when you've remembered something else that's really important, you can then select back to amend your 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, right back on that first page, with a copy of your submission.

This will include the response ID number of this application form. Please ensure that you keep a record of this response ID for your future reference. You will need this number to submit your multiple forms and have them linked. And if you have any follow-up with the TGA, this is a good number to have. Once you've submitted the application form or forms, you will need to pay the application fees. Applications for consent cannot be processed until all the applicable fees have been paid in full.

The current fees for applications for consent to supply apply to each ARTG entry and application for inclusion included in the application. The fees are currently at $500 for the first ARTG entry or application for inclusion and then $100 for each subsequent ARTG entry or application for inclusion in that application for consent. For example, if your application for consent has 55 ARTG entries, $500 is applied to the first ARTG entry and then $100 to each of the remaining 54 ARTG entries, which equates to the application of consent costing $5,900.

As long as you advise on that applicant details page that you are going to submit multiple forms and you've provided the ID number of the first form in your subsequent forms. You have submitted all of those forms within 24 hours of each other, then these forms can be linked for fee payment and you will not be charged that $500 for the first ARTG entry for each form.

Consent to supply that only relates to non-compliant patient information materials has a different risk profile assessment and follow-up, when compared to consent applications relating to other essential principles. Therefore, the TGA has proposed to government to amend the current regulations to have the fee for applications for consent that only relate to essential principle 13A patient information materials, change to be a flat fee of $30 for each ARTG entry or application for inclusion.

This means that for an application for consent for non-compliance with essential principle 13A, where there are 55 entries, the total cost would be $1,650. The TGA has also proposed that this fee reduction be applied retrospectively to applications for consent for essential principle 13A only, as far back as 1st January 2021. If this proposal is accepted, there will be a refund of fees applied to all of those applications that have been processed already.

It is expected that a decision will be available early November on the proposed amendments. But please remember, if you are submitting multiple forms due to having more than 20 ARTG entries or applications for inclusion, please submit all of those forms within 24 hours to avoid that initial $500 fee for the first ARTG entry or application for inclusion being applied to your subsequent applications for consent.

There are two ways to pay the applicable processing fees. There's an immediate payment. In this process, you have to calculate the total fees based on the current fees and pay immediately after completing and submitting the application. Or you can do a payment against invoice. If you require the TGA to raise an invoice for payment, simply complete and submit your application for consent and the TGA will raise and send the submitter an invoice for processing the fees.

If you do wish to make an immediate payment, calculate the total fees for your application based on the total number of ARTG entries or applications for inclusion for that application for consent. Which is, of course, the $500 for the first ARTG entry and then $100 for each of the remaining ARTG entries, as described in the previous slide. Then you go to the TGA payment page and there is a link there. In the Biller Code, choose option nine, which is exemption under section 41MA device, S41MA device.

Enter your TGA electronic business system ID number, your tBS ID number, in the box provided. And enter one ARTG or application for inclusion number, preferably the first one that you had in your first application, in the invoice number box provided. Enter the total amount in fees to be paid in Australian dollars. Select the payment method and then follow the instructions to complete the credit card payment.

Again, if you are choosing this payment option and you're submitting multiple forms, please make sure that you submit them within 24 hours and 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 form submission may be charged as a new application. Once the fees have been paid, the post-market team will receive the application.

If insufficient information or documents are provided in the application, you will be emailed to provide us with that missing information. In the case of consent to supply devices with non-compliant patient information material, to ensure that supply of medical devices are not adversely affected if we receive a large volume of applications for consent, you may receive your consent to supply prior to a detailed assessment of the implementation plan.

However, as a result, you may be required to provide that additional information after consent has been granted. An email with consent to supply decision notification will be sent to the submitter to inform you of the decision. During the period of approved non-compliance, you may be required at any time to demonstrate that you are following the approved implementation plan. Please be aware that consent may be withdrawn at any time if there is non-compliance with the approved implementation plan.

Or if the implementation plan is audited and it is deemed insufficient to mitigate the non-compliance, if there are any concerns at all by the TGA regarding the implementation plan, you will be provided with an opportunity to amend that plan and address any of those concerns that we've identified. At the end of the consent period, you will be required to provide a submission regarding the compliance of the devices to all of those essential principles.

As mentioned earlier, this is the first stage of the modernisation of the consent to supply process. And we will keep you updated with further information as this 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 the entire project to be completed before deployment.

The next stage of the modernisation programme is to have the form available from your login through the TGA electronic business services, tBS, eBS login. This is scheduled for the beginning of 2022, but we are always hopeful for an earlier release. What this means is that your details will prefill the form when you begin your 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 TGA post-market database where we'll be able to push limited notifications to you as a sponsor through your sponsor compliance dashboard. The next phase will be to integrate the applications for inclusion into the e-forms in eBS, as well as integrating directly with billing services. Allowing that extra functionality and prefilling within your application form.

In addition, the notifications that can be presented and the submissions that you can then provide back to us will be directly through the post-market compliance dashboard. And those notifications will be able to increase as well. This means that when you need to provide your evidence of compliance at the end of the consent period, you can just simply do this by submitting the compliant detail documents through that sponsor dashboard.

We will provide you with similar emails, web updates and webinars as this project progresses. And if at any time you want to contact us on any of the information that we've provided here or in terms of your consent or any of the post-market things, you can contact us on this email address here. I'll just introduce, this is Kate Fuller. And she works in our team as well in the post-market reforms and reviews section.

And Kate is going to help me out with the questions that have come in. She's been having a look at these. And we'll go through these now. If there are any questions that we don't get to and we're able to see who has sent them to us, then we'll provide you with some out-of-session answers to those questions. But as I did say earlier, you can always send any questions to us at that post-market devices email address as well. Kate, what do we have?

Kate Fuller

I've got a question here. If I submit a consent to supply application, do I need to wait to receive TGA confirmation of acceptance before I can supply the non-compliant product? Or can I supply whilst the TGA is reviewing this application?

Amanda Craig

You shouldn't supply any devices that are non-compliant without consent from the secretary, as that is a breach of section 41MA and 41MAA. You will need to wait until you do have consent from the secretary.

Kate Fuller

I've got another question. Does this consent only refer to a valid EC or ISO 13485 certificate? Can we import a medical device under this consent if the EC certificate has not been renewed or withdrawn?

Amanda Craig

That's a very good question. And this is a very different part of the act. Conformity assessment procedures, your manufacturer's evidence is not dealt with under a consent to supply with non-compliance with the essential principles. You will need consent from the minister to supply products if you have an issue with conformity assessment.

However, if you are having problems with conformity assessments such as lapses in conformity assessments due to issues such as being scheduled for a later notified body audit, then if you look on our website, we have a paper on that as well. And we're happy to provide a link to you as well on that. But that is a completely different process than consent to supply for non-compliance with essential principles.

Kate Fuller

Just had a question come in around the fees and the change and the timing around the potential change in fees. When does this $30 fee for patient information come into effect? For example, if I submit my application this week, should I pay the $30 or do I pay the 500 plus 100 per ARTG?

Amanda Craig

And that's great to clarify that. Great question. It is not in place at the moment. At the moment, you need to pay $500 for your first ARTG entry and $100 for every subsequent ARTG entry in that application. The fees have gone to government for a decision, that amendment to the regulations. Government will not make a decision on that until the end of October. We won't know until November whether government has accepted that proposal and we can change those regulations.

We cannot process that application fee if you don't pay the full fees at the moment. But at that same time, we've also asked that there be that refund in fees as well. If the proposal goes ahead, we are hopeful that the refund proposal will also go ahead hand in hand.

Kate Fuller

Thanks for clarifying that, Amanda. Got another question here. If we have manufacturers' stock on hand in a warehouse that was supplied prior to 1 December 2021 and do not have compliant patient information materials, since they're already received by the sponsor in their warehouse. Do they still need to be labelled by the new implant cards or should a consent be applied for to supply these devices in the Australian market after 1 December?

Amanda Craig

This is another really good question on the supply. What counts as supply? You importing stock from a manufacturer is not supply. Supply is going out to the customer from the sponsor. As a sponsor, if you're supplying that medical device after 1st December 2021, the legislation says that those devices must have patient implant cards and patient information leaflets supplied with the device from 1 December 2021.

You can have that as an outsert on your device when you're supplying that, because it's with the device. If you want to put your compliant patient information card and leaflet on the devices, you send it out, because it's stock on hand, then that's great. But otherwise, you will need a consent to supply non-compliant goods.

Kate Fuller

Another question here around, I guess, the proposed regulation changes. If the TGA is going to publish product information for devices electronically in November, does this mean the requirement for patient information leaflets is met? I'm assuming that's a question around electronic PILs as also compliance.

Amanda Craig

Yes. As it stands at the moment, the legislation says that we must provide this information with. Similar to the fee change, we've also gone to government to ask for more flexibility in that regulation so that we can allow electronic patient information leaflets. And we're just waiting for that to come back also on 1st or the beginning of November. Hopefully the government will also agree with that change.

And then, yes, an electronic PIL, patient information leaflet, would then be compliant. You would not need consent then. This early November is an important time for us.

Kate Fuller

Are you able to provide us some examples of the type of evidence that would be requested by the TGA to demonstrate compliance to the mitigation strategy?

Amanda Craig

Yes, absolutely. Perhaps in your mitigation strategy, you're saying that you have stickers or something in the boxes or that your stickers have sufficient information to counter the missing information on that patient implant card. Then what we would expect to see is perhaps an image of what those stickers look like. And that it does marry up with all the information that's needed. Sometimes what will happen is a patient may say that they got a patient implant card that was non-compliant and they'll send us a picture.

And we'll want to see what it is that's actually been provided and whether this has worked well, the implementation plan.

Kate Fuller

We've got a couple of detailed questions on PICs and PILs. But before we get to that, there is another question just in regards to, I guess, evidence of compliance. And one of those is, will there be an option at some stage on the sponsor's portal to submit the PIL and PIC associated with the ARTGs to show that they are compliant the towards the end of the completion of the consent?

Amanda Craig

Absolutely. And that's what we're looking to build to. We're hoping around mid next year, that that functionality will be built as well and deployed. That then there will just be somewhere that you will be able to just upload those documents. And we won't be then asking you for anything else. You'll just be able to demonstrate that they're now compliant, your compliant PIC or PIL.

Kate Fuller

And I've got a few questions here that are detailed around PICs and PILs. The first one, if the manufacturer will have EU MDR and Australian regs compliant products containing the PIC and PIL with the device by April 2022. Is it acceptable to not supply a PIC or a PIL from 1 December 2021 and having the consent application, a plan, that the plan is not to supply a PIC or PIL until the newly manufactured device is started in April 2022?

Amanda Craig

While I'm hugely in favour if we have something that's going to be compliant so much ahead of the EU 2024 date, that's still quite some time when patients are expecting to receive a patient implant card. It's not going to be acceptable to not supply anything to patients. The reason for this legislation was to provide patients with this extra information to inform them on what they have implanted within them. And to be able to have those appropriate consent or informed consent discussions about what the risks are with these implantable devices.

It's really important that patients have something in that time period. If it's a printout or something that's an outsert, we're happy to look at any of those solutions that you can come up with to assist those patients in having something from 1st December through to when you can be compliant.

Kate Fuller

Got a question around asking us to clarify the process for change of address. The currently supplied device needs to have an interim PIC supplied. This will be provided by the sales teams as they deliver each device. The manufacturer's name on the current device labelling will be changed when they comply with EU MDR in April 2022. The manufacturer has provided a copy of this PIC for the sponsor to print locally to provide with the device.

This PIC has then changed, i.e., new manufacturer's address. Is a consent form needed in this instance?

Amanda Craig

If the manufacturer's address is going to be incorrect, then you will need a consent form, because it doesn't have the correct manufacturer's address. If the manufacturer wanted to authorise the sponsor to print out the new cards to be compliant, then you may want to consider whether there's another option for how those patient implant cards could become compliant for that time.

Kate Fuller

Got a question around, how long will it take for consent to be approved?

Amanda Craig

It does depend on what the application for consent is and the information that's provided. If this is for patient implant cards and patient information leaflets, this will be a rapid turnaround, because the risk is relatively low compared to those other essential principles. If it's a patient implant card and patient information leaflet, as I mentioned, we may do review of that implementation plan post consent being approved.

I would expect that we're looking at a turnaround time of within a week. Again, the thing that may be the hold-up is making sure that the fees are actually paid. That bit, of course, is on the sponsor and manufacturing. But as soon as the post-market team receive the application, I would imagine that it can be done within the week.

Kate Fuller

I've got a question here around date-stamping and version control. In the patient information materials guidance document, it requires that a PIL must clearly state the date of release of the information. Labelling IFUs are normally document-controlled with characters that don't necessarily refer to a date. Can you please advise whether a date of release of the PIL is obligatory? Is that mandatory?

Amanda Craig

It's not mandatory to have the date on there. But what you want to consider, when we're considering patient information leaflets and patient implant cards, the leaflets more so, you want to make sure that the patient is receiving the most up-to-date information. And how the patient knows whether the information they're receiving is up to date, is the correct version.

If you have something at the bottom of the form that is only intelligible for the manufacturer and they can only determine that through their quality management system, then that's not very helpful for a patient. While it's not mandatory, it is something that we encourage so that the patients know that the information they're receiving is the most up to date.

For all of this information, you should always put the patient in the forefront of your mind when you're reviewing your documents to see, is this going to be useful for the patient? Because that's the reason why we're doing this.

Kate Fuller

I'm just having a look at time. We've got one more minute. Let's just talk about e-PILs again. If e-PIL is approved by the government, does that sponsor need to provide any information with the device to direct the consumer to the e-PIL location?

Amanda Craig

That's a really good question. If it is not really evident on your web page on how to get to that patient information leaflet and your patients or healthcare professionals need to do lots of searching. And even if they did lots of searching, they couldn't find the patient information leaflet, you're going to have to provide that link because otherwise, it's non-accessible. The patient information leaflet needs to be accessible to the patient.

Again, just thinking about how that's going to be able to be accessed. That is definitely how I wind up. I can hear the music in my ears now.

Kate Fuller

We have a couple of other questions here. But like you said, I'm sure that we can get in touch with those people to answer their questions directly.

Amanda Craig

Thank you so much, Kate and Rachel. And thank you everyone for joining us today.