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Applying for a Consent for Non-compliance
Are we still permitted to use the TGA paper-based proforma for the consent for non-compliance or do we need to use the online form in the TGA Business Services (TBS) portal?
No - The paper-based application form has been removed from the TGA website and all consent applications should be submitted through the online application form available in the TGA Business Services (TBS) portal. The online form has additional questions required as part of the consent process for devices with non-compliant patient information materials, so it is important that the online form is used for all consent applications.
What is the review timeline for a consent application?
The TGA is unable to process any application until all relevant fees are paid in full. Once the fees have been paid, the average review and processing time for an application is five working days. The review timeline will be extended if the sponsor has not provided sufficient information in the implementation plan and risk mitigation strategy including details of how the non-conformity is being addressed and how consumers are being informed about the breach.
Do I have to wait for the consent application to be approved before continuing to supply affected devices that do not have compliant patient information materials after 1 December 2021?
Yes - The consent must be in place on, or before 1 December 2021 to ensure continued supply of affected devices. This includes payment of application fees and approval from the delegate of the Secretary, which involves the sponsor receiving a notification letter that specifies the consent has been granted. If you do not have a consent in place by this date, you must cease supply of the non-compliant device(s).
If an invoice is requested for the consent application, how long will it take for the invoice to be raised and sent to the sponsor?
The turnaround time for raising an invoice by the TGA is generally two working days.
When does the new $30 flat fee for consent applications related to patient information materials come into effect?
On 29 October 2021, the Therapeutic Goods (Medical Device) Regulations 2002 were amended to provide a fee reduction for applications for consent solely related to non-compliance with EP 13A (patient information materials). The fee is now $30 for each ARTG entry / Application for Inclusion in the consent application.
The fee reduction will be applied retrospectively. Sponsors who applied and paid on or after 1 January 2021 for consent solely related to non-compliance with EP 13A can apply for a refund of the difference in the fees between what they paid and the new reduced fees. Sponsors should email mdconsent@health.gov.au if they believe they are eligible for a refund.
Note: For consent applications related to other Essential Principles (different, or in addition to EP 13A), the normal processing fees of $500 for the first, and $100 for each subsequent ARTG entry/Application for Inclusion applies.
When does the new $30 flat fee for consent applications related to information with medical devices that are transitioning to the EU MDR/IVDR come into effect?
On 29 September 2022, amendments to the Therapeutic Goods (Medical Device) Regulations 2002 came into effect to introduce fee concessions. The concessions reduce the regulatory costs for sponsors of ARTG entry(s) supported by EU MDD/IVDD certifications transitioning to the EU MDR/IVDR and who are seeking consent to import, supply, or export their devices where they do not have compliant information to be provided with their medical devices (EP13).
The application fee for consent has been reduced to a flat $30 per ARTG entry where the application is made solely in relation to non-compliance with EP 13 (information supplied by the manufacturer) and the non-compliance is due to transitioning from EU MDD/IVDD to EU MDR/IVDR certification. This fee reduction will be applied retrospectively to applications made from 1 January 2022 (i.e.: a refund will be provided for the difference in fees where a higher fee has already been paid by eligible sponsors). Standard fees apply for consent applications where the medical device does not comply with any other Essential Principle(s).
Sponsors with a consent in place who believe they are eligible for a fee refund should contact the TGA at mdconsent@health.gov.au identifying the relevant consent application. Once the refund request is validated, it will be forwarded to the Cost Recovery Management Section team who will contact the sponsor regarding the refund.
Note: For consent applications related to other Essential Principles (different, or in addition to EP 13) or who are not transitioning to the EU MDR/IVDR, the normal processing fees of $500 for the first, and $100 for each subsequent ARTG entry/Application for Inclusion applies.
Is there a time limit for the duration of consent for non-compliant devices? How long can we seek consent for?
Yes - In general, consent is only granted by the delegate of the Secretary for a maximum period of 2 years.
If the TGA approves the consent for a device that is part of an Application for Inclusion, will I need to inform the Devices Applications Section that the consent has been approved or will the consent approval be provided internally to the Devices Applications Section?
No - If the device is part of an Application for Inclusion, you do not need to inform the Devices Applications Section of your application for consent. The TGA processes will ensure that the Devices Applications Section are informed about the consent application and progress of the decision. The Devices Applications Section will be advised when the notification is sent to the sponsor so there is no need for sponsors to contact them in this regard.
If I have an approved consent for device that is part of an Application for Inclusion, do I need to tell the TGA when the Application for Inclusion is approved, and the device is included in the ARTG?
Yes - If your Application for Inclusion is approved and your device is included in the ARTG, you should contact the TGA at mdconsent@health.gov.au identifying the relevant consent application, the application for inclusion number and new ARTG number for the recently included device. The TGA will then update the consent with the new ARTG number and issue an updated consent letter.
What do I do if a device that is part of an approved consent application is reclassified and as a result is issued a new ARTG?
Sponsors with an approved consent application for an ARTG entry that has been reclassified should contact the TGA at mdconsent@health.gov.au identifying the relevant consent application and ARTG entries. You do not need to reapply for consent. The TGA will provide you with an approval for the new ARTG entry for the same approved duration.
Is there an option on the new sponsor compliance dashboard to submit evidence of compliance with the Essential Principles (EPs) to demonstrate compliance at the end of the consent period?
Yes - The TGA has developed an integrated online solution in the TGA Business Services portal (TBS) where sponsors can submit evidence of compliance for their devices before the end of the approved consent period. When a consent application is approved, a notification and letter of approval is issued and will be able to be viewed on the 'Notifications' view of the Consent for Non-compliance Dashboard. Sponsors can provide evidence of compliance as part of their response to the approved notification. Sponsors may provide evidence multiple times during the consent period if devices become compliant with the EPs at different times during the consent period. Please refer to the Consent for Non-compliance Dashboard guidance document on the TGA website for more information.
How do I request an extension to the approved consent period for my devices?
You can submit a request for an extension to the due date of an approved consent application through the Consent for Non-compliance Dashboard in TBS by requesting an extension to the response due date to the consent approved notification for the relevant application. An extension request can only be submitted by authorised users with submitter access for the TBS sponsor portal and only for consent applications that are current and have not expired. An email notifying of the extension request decision will be sent to the sponsor. Please refer to the Consent for Non-compliance Dashboard guidance document on the TGA website for more information.
Can a consent application be submitted for a device whilst awaiting a decision on a Device Change Request (DCR) so that the device can continue to be supplied?
A consent application can be submitted for the non-compliant device in order to continue supply, however devices that are non-compliant with the Essential Principles cannot be supplied until consent is granted by the TGA. The TGA cannot guarantee that consent would be approved prior to a DCR being approved.
Applications for Inclusion and stock before 1st December 2021
Is a consent for non-compliance needed for an implantable medical device Application for Inclusion that was submitted before 1 December 2021 and included in the ARTG post 1 December 2021, in relation to the requirement for patient information material?
Yes - Applications for Inclusion for implantable medical devices that require a PIC/PIL that will not have compliant patient information materials by 1 December 2021, need to have an application submitted for consent to supply non-compliant patient materials, and be granted a consent for non-compliance. Applications for Inclusion will only be approved after consent has been granted (provided there are no other outstanding issues with the application).
Is the consent for non-compliance applicable to implantable devices imported into Australia in the last year but that have not yet been sent out to healthcare facilities?
Yes - From 1 December 2021, all implantable medical devices that are being supplied in Australia must have compliant patient information materials. For example, if the importation occurred prior to 1 Dec 2021, and the sponsor is supplying the devices from their warehouses to healthcare facilities after 1 Dec 2021, then patient information materials will be required for the devices.
Implementation plans
How does the TGA plan on verifying that the implementation plans are appropriate and being carried out? Will every implementation plan be audited, or will it be a random selection?
A risk-based approach will be used to audit a selection of implementation plans during the consent period to verify that they meet requirements and are being appropriately applied. Sponsors will be contacted and requested to provide further information, if necessary. At the end of the consent period the TGA expects the sponsor to provide evidence of compliance.
Will the TGA be providing a template for implementation plans to keep information consistent with each sponsor?
No - Currently there is no template for an implementation plan, however information required as part of the implementation plan is outlined in the Patient Information Material Guidance document on the TGA website.
Can the TGA provide examples of the types of evidence that is required to demonstrate compliance with the implementation plan?
It is expected that each manufacturer's situation is different and therefore the types of evidence will vary; the TGA will work with sponsors on a case-by-case basis if further evidence of compliance is required.
However, an example might be that consent is sought for a non-compliant PIC due to the lack of the manufacturer's details provided on the card. The interim solution as outlined in the implementation plan might be to place a sticker on the PIC for healthcare facilities to fill in the manufacturer's details, and that by the end of the consent period, the manufacturer's details will be printed onto the cards for supply. In this scenario, the TGA may request a copy of the PIC at the end of the consent period to ensure that it is fully compliant with EP 13A and that the manufacturer's details are now printed on the card as planned.
Alternatively, a patient implant card may contain the sponsor details instead of the manufacturer's details. The implementation plan may include a staggered approach to introduce cards with the manufacturer's details on the card for different models of devices. The TGA may request a copy of the PIC at those timepoints during the consent period to ensure the implementation is proceeding as expected.
Patient Implant Cards and Patient Information Leaflets
What does the TGA consider non-compliant patient information material?
Non-compliant patient information materials are Patient Implant Cards (PICs) and Patient Information Leaflets (PILs) that do not comply with the requirements set out in Essential Principles 13A of the Therapeutic Goods (Medical Device) Regulations 2002. The Patient Information Material Guidance document on the TGA website can provide additional information.
If the Patient Information Leaflet (PIL) is compliant but the Patient Implant Card (PIC) is not, can we seek consent for non-compliant PICs only?
Yes - The sponsor can seek consent for non-compliant PICs only by selecting the specific Essential Principle related to PICs in the consent application. Conversely, sponsors can seek consent just for PILs if the PIC is compliant.
Do I need to apply for consent if the manufacturer plans to release the devices with patient implant cards and patient information leaflets from 1st December 2021 from their site?
No - If the patient information materials will be compliant on 1 December 2021, when the devices are to be supplied, then consent for non-compliance is not required.
Is it considered to be compliant if a sales representative provides a device to the hospital and also provides a patient implant card directly to the patient? i.e. if PICs or PILs are not provided packaged with the device, but provided by the sponsor at the time, or before the device is supplied to customer?
Yes - The Therapeutic Goods (Medical Device) Regulations 2002 has been amended to allow for more flexible provision of patient information materials (PICs / PILs) for implantable devices and AIMDs. It is no longer a requirement that PICs and PILs are supplied directly with the device if they contain all required information and are made available in a way that is readily accessible by the patient concerned. The PICs and PILs can also be supplied electronically rather than as hard copies if they contain all required information and are provided in a way that is readily accessible by the patient concerned.
In cases where a physical patient implant card is supplied with the device, and the manufacturer and device information is also provided with the device, but as a sticker that is required to be adhered to the card at the point of care, is this considered compliant with the requirements?
Yes -This is compliant as long as all the information on the card is legible, and the sticker does not cover any other part of the card where other information is provided.
Electronic Patient Implant Cards and Patient Information Leaflets
If a manufacturer plans to provide an electronic PIC, do they need to provide a hard copy PIC with the device itself or provide any information with the device that directs the patient to the location of the electronic PIC?
Electronic PICs and PILs must contain all required information outlined in the Regulations and be readily accessible by the patient. To be compliant, the sponsor or manufacturer will need to provide directions or guidance to ensure that patients can readily access the information.
Device Specific questions
Does the TGA intend to require sealants and haemostatic agents to be supplied with PICs and PILs even though these products are normally resorbed over a 6-month period?
Yes - Currently, all resorbable devices require PICs and PILs. Future regulatory changes may result in resorbable devices not requiring PICs and PILs if the devices are resorbed within a certain timeframe.
Transition from EU MDD/EU MDR
Do I need to complete a consent application to advise the TGA when the manufacturer’s EU MDD certification expires?
A different form should be used for this process. You need to use the appropriate form and guidance for lapses in conformity assessment certification.
There may be cases where the manufacturer becomes aware, through recertification, that the medical devices being supplied under the previous conformity assessment certification are non-compliant with the Essential Principles. In those cases, you should apply for consent to supply non-compliant medical devices if you wish to continue to supply those medical devices.