The Therapeutic Goods Administration (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.

Before continuing to supply affected devices that do not have compliant patient information materials after 1 December 2021, the consent application must be approved in place on or before 1 December 2021, to ensure continued supply of affected devices. If you do not have a consent in place by this date, you must cease supply of the non-compliant device(s). 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 consent application only refers to a valid EC or ISO 13485 certificate, medical devices cannot be imported if the EC certificate lapses or is withdrawn. 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.

Considering the types of evidence that is required to demonstrate compliance with the implementation plan, it is expected that each manufacturer's situation is different for the types of evidence, 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 (Patient Implant Card) 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.

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. 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.

 

 

References:

Essential Principles - consent for noncompliance

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