Therapeutic Goods Administration (TGA) Australia has published an updated guidance document on medical device patient information leaflets (PIL) and implants cards (including acceptance of Implementation Plans) in October 2021.
The main update is the inclusion of a section about patient information materials that are non-compliant with the Essential Principles, whereby all implantable medical devices are all implantable medical devices are required to have patient information materials available in the form of both Patient Information Cards (PIC) and PIL. The implementation date for this update is 1 December 2021.
TGA will consider providing approval or consent for the importation, supply and exportation of a medical device that does not comply with the requirements completely. This consideration will be for sponsors of medical devices currently in the ARTG and will not be able to provide compliant PICs/PILs by 1 December 2021. The consent can be applied for by authorised representatives of a sponsor and must be in place prior to 1 December 2021 to ensure there are no disruptions to the supply of an affected device.
Regarding the consent application forms, TGA is modernising the process by transitioning from using paper forms to using online forms, which will streamline the application process and improve functionality. These forms can be found on the TGA website. For each ARTG entry / Application for Inclusion, the fees are $500 for the first application and $100 for each subsequent application.
The submission of an Implementation Plan is also required if applications for consent are submitted. The plan should provide details about the device(s) and how it will comply with the regulatory requirements for both the PIC and the PIL and other pertinent details.
More details can be found in “Medical device patient information leaflets and implant cards, Version 1.5, October 2021”: https://www.tga.gov.au/sites/default/files/medical-device-patient-information-leaflets-and-implant-cards.pdf