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Consent for Non-compliant Medical Device(s) - Frequently Asked Questions

1 December 2021

No - The paper-based application form has been removed from the TGA website and all consent applications should be submitted through the new 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 this new online form is used for all consent applications from now on.

The TGA is unable to process any application until all relevant fees are paid in full. If you are not intending to make an immediate payment after submitting your application and choose to wait for the TGA to raise and send an invoice for payment, it is recommended that you submit the application at least a week prior to the proposed consent start date. This is to allow for the standard finance processing timelines.

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).

The turnaround time for raising an invoice by the TGA is generally two working days.

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 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.

Yes - In general, consent is only granted by the delegate of the Secretary for a maximum period of 2 years. However, as there is a change in the Australian regulations for patient information materials prior to the European Union regulations coming into effect concerning non-compliant patient information materials, consent for these applications will be granted up until 25 May 2024.

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.

Yes - The TGA has developed an integrated online solution in the TGA Business Services portal (TBS) where sponsors can view draft and submitted consent applications. The next phase of the integrated online solution will incorporate the functionality to submit evidence of compliance at any time during the consent period.

No - Consent is granted for non-compliance with the Essential Principles and is not the correct pathway to apply for continued supply due to conformity assessment certification lapsing or becoming invalid. All manufacturers must hold valid conformity assessment certification to continue importation into, or supply of devices within Australia. Further information on lapses in conformity assessment certification can be found in the TGA's approach to delays in medical device conformity assessment recertification.

Applications for Inclusion and stock before 1st December 2021

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).

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

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.

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.

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

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.

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.

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.

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.

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

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

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.