AusBiotech and its AusMedtech Regulatory Affairs Expert Panel have made a submission to the TGA in full support of the recommendation to up-classify surgical mesh products to align with the revised European regulations.
AusBiotech said it supports the criteria and implementation of comparable overseas regulators on medical devices as described in the TGA’s consultation paper. However, AusBiotech recommends greater clarity with regard to the requirements around specific the provision of patient implant cards or timelines.
The Australian Government outlined its program for regulatory reform in its response to the recommendations detailed in the Review of Medicines and Medical Devices Regulation (MMDR).
The TGA’s consultation paper addresses the Government’s "…decision in September 2016 to accept Recommendation Twenty of the Expert Panel Review of MMDR..." from Class IIb to Class III.
This is on line with the MMDR’s recommendation that the regulation of medical devices by the TGA is, wherever possible, aligned with the European Union framework.
AusBiotech is said in its submission that it supports patient safety, specifically through the provision of information supplied to patients and caregivers. However, the introduction of a patient card has been attempted through other regulatory agencies and proven to be of no value, and in some instances, unsuccessful.
The requirement for the Manufacturer to provide such information for a patient with the assumption they have it on their person at all times, is not realistic or beneficial in many instances. The importance of the availability of such information is in some cases not understood by the patient and more importantly not available at the critical time it may be needed by the healthcare provider.
AusBiotech instead recommended the introduction of a voluntary option for providing the patient card as part of meeting Essential Principle 13 and suggested the consideration of existing platforms of Medical Records for the supply of specific device information, including websites which would allow the manufacturers content to remain up-to-date, through to other systems such as the Medicare system etc. This would not require additional steps by the manufacturer nor health practitioners, but would allow the availability of such information to both the patient and the healthcare provider when and if required. It would also allow the responsibility to be removed from the patients directly who will have to ensure the patient implant cards are always readily available.
The transition arrangements in the EU will end in May 2024. The Australian transition should therefore be scheduled to end on 30 November 2024, around six months after the end of the EU transition.
To read the full submission can be viewed online.