The CHF supports the reintroduction of pills into the scope of the remade Order. The omission of these from the current Order is an unfortunate regulatory oversight. Consumers implicitly trust the regulatory system to ensure any product made available to them undergoes rigorous assessment of quality, safety and efficacy. Currently that trust is being abused.
We expect the primary impact of the reclassification for consumers will be a greater level of quality for Active Medical Devices in terms of reliability, safety and effectiveness. By putting these medical devices into a higher class they will undergo more rigorous assessment prior to becoming available to consumers, decreasing the risk to consumer health of the devices not functioning as intended.
The CHF acknowledges that there is potential for a delay in accessibility for critical medical devices should certain devices be reclassified into a higher Class. However we believe that it is crucial that any such critical devices be rigorously assessed for safety, efficacy and quality before being made available to ensure faulty or ineffective devices are not given to consumers. Additionally we believe the proposed transitional arrangements should give manufacturers and sponsors sufficient time to ensure their devices are assessed appropriately and are able to be made available to consumers when the new classification applies.
At the heart of CHF’s policy agenda is patient-centred care. Our responses to the TGA’s consultation has been formed with a patient-centred approach in mind.
CHF notes that this consultation’s scope is limited to the regulatory guidance in line with existing regulatory requirements, and not changes to those regulatory requirements. However, as other consultations are currently open to change regulations for Software as a Medical Device (SaMD) it would be remiss for CHF to not include some forward-looking advice on out of scope but related matters.
CHF appreciates the opportunity to provide a comment in response to proposed changes to a number of definitions and the scope of the medical device regulatory framework in Australia.
At the heart of CHF’s policy agenda is patient-centred care. Our responses to the TGA’s consultation questions have been formed with a patient-centred approach in mind.
During 2019, the Therapeutic Goods Administration (TGA) will continue to implement changes in response to the Review of Medicines and Medical Devices Regulation (MMDR). This webinar aimed to update consumers on these medical device consultations and answer questions from consumers.
This position statement has been developed by the Consumers Health Forum of Australia (CHF) and the Centre for Health Policy, the University of Melbourne. It has been informed by the discussions at a Specialist Fee and Performance Transparency Roundtable held at the University of Melbourne on the 12 June 2018 and other consultation such as CHF’s Out of Pocket Pain survey.
The statement has been endorsed by:
Melbourne Institute: Applied Economic and Social Research - University of Melbourne
Australian Healthcare and Hospitals Association
This submission is prepared in the context of an imminent federal election. CHF will be putting out an election priorities document which sets out our proposed agenda for health reform for through to 2025.