You are here
Consent for Non-compliant Medical Device(s) - Frequently Asked Questions
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 on the TGA Consultation Hub?
No - The paper-based application form has been removed from the TGA website and all consent applications should be submitted through the new interim online application form available on the TGA Consultation Hub. 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.
What is the review timeline for a consent application? How far in advance should I apply to ensure continued supply of affected devices from 1 December 2021?
Consent for non-compliance related to EP 13A for implantable devices must be in place by 1 December 2021 to ensure continued supply of the affected devices. 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 by 20 November 2021. This is to allow for the standard finance processing timelines and to accommodate for the large number of anticipated invoices being requested in the lead up to the 1 December 2021 deadline.
Do I have to wait for the consent application to be approved before continuing to supply affected devices 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.2 and /or 13A.3 (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.
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. 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.
If the TGA approves the consent for an Application for Inclusion, will I need to inform the Devices Applications Section that it 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.
Will there be an option on the new sponsor compliance dashboard to submit evidence of compliant PIC/PIL information to demonstrate compliance at the end of the consent period?
Yes - The TGA is currently developing an integrated online solution in the TGA Electronic Business Services portal (tBS) where sponsors will be able to view current and previous consent applications and submit evidence of compliance at any time during the consent period. It is planned that the new form will be available in early 2022.
If the consent application only refers to a valid EC or ISO 13485 certificate, can medical devices still be imported if the EC certificate lapses or is withdrawn?
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
Is this provision applicable to device Applications for Inclusion that were submitted before 1 December 2021 and listed in the ARTG post 1 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).
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.
- Tags:FAQ, medical devices
- URL:https://www.tga.gov.au/node/941549