AusBiotech, supported by the AusMedtech Regulatory Affairs Expert Panel, has submitted to two medical device consultations that form part of the Medicines and Medical Devices Review (MMDR).
The consultations seek to streamline medical device assessment and AusBiotech has offered comment on proposed planning.
AusBiotech’s two submissions, Accelerated assessment of medical devices – Priority Review pathway and Designation of Australian conformity assessment bodies for medical devices, were submitted on 11 January 2017 on behalf of industry.
Accelerated assessment of medical devices – Priority Review pathway
AusBiotech supports the addition of a Priority Review pathway to expedite approval of medical devices in certain circumstances, and contends that the proposed pathway will continue to require medical devices to meet the essential principles, including clinical evidence requirements.
However, there is concern that the proposed pathway may lengthen wait times for the vast majority of industry members if the pathway is not adequately resourced. The availability and accessibility of subject matter experts, which would enable rapid assessment of applications, may be limited since these devices will be incorporating novel technologies and/or clinical applications.
Designation of Australian conformity assessment bodies for medical devices
AusBiotech also supports a system that designates bodies for medical devices to undertake conformity assessment certification of medical devices, including in vitro diagnostic medical devices (IVDs), for the Australian market.
However, it is unclear whether the system proposed by the TGA will translate into reduced review times or costs for patients, industry and/or government. AusBiotech recommends that the TGA undertake research to determine whether such a system would be both utilised by industry and be viable in Australia given potential cost, capacity, skills and experience constraints. AusBiotech also encourages the TGA to engage with European notified bodies to gauge their interest in obtaining designation to review under the Australian regulations.
About the TGA’s Medicines and Medical Devices Review (MMDR)
These two submissions were made as part of the TGA’s medical device consultations, which invites comment on the proposed accelerated pathways for medical devices and Australian conformity assessment bodies for medical devices. These consultations were announced as further consultations on elements of the MMDR, which will be rolled out by March 2017.