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Consent for non-compliant Medical Device(s): Frequently Asked Questions
Applying for a Consent for Non-compliance
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.
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.
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 firstname.lastname@example.org 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.
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 email@example.com 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.
Yes - In general, consent is only granted by the delegate of the Secretary for a maximum period of 2 years.
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 - If your Application for Inclusion is approved and your device is included in the ARTG, you should contact the TGA at firstname.lastname@example.org 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.
Sponsors with an approved consent application for an ARTG entry that has been reclassified should contact the TGA at email@example.com 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.
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.
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.
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
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.
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.
Transition from EU MDD/EU MDR
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.