Australia’s Therapeutic Goods Administration (TGA) released a three-part medical device action plan, part of which will make adverse event reports more timely, as well as enhance public awareness on and the agency and device regulatory system.
The plan also identifies additional opportunities for TGA to increase transparency, with stakeholder consultations on proposed changes to regulatory requirements and forthcoming guidance materials.
Until early 2020, potential changes to be discussed include requiring mandatory audits of more medium-risk devices applications prior to market entry, enhancing TGA’s program for conducting manufacturing site inspections and publishing more information on regulatory decision-making processes for individual high-risk devices.
For certain high-risk devices like spinal implants, TGA will also consult on requiring “greater levels and scrutiny of clinical evidence.”
Changes to current regulations applicable to software as a medical device (SaMD), broadening the scope of regulation on 3D-printed devices, policy clarifications on medical device cybersecurity requirements and the introduction of a new unique device identification (UDI) system in Australia are other initiatives described in the action plan.
TGA advanced the initiatives to better reflect software risk through a December 2018 SaMD regulatory guidance
, a February SaMD consultation
, and a device cybersecurity consultation
, as well as a January consultation
for establishing a UDI system. TGA also issued
guidance on medical devices subject to patient implant cards and patient information leaflets in August 2018.
For devices of concern, TGA said it will also establish expert working groups, with consumer representation, to provide advice and feedback on devices of concern. These will include a women’s health products working group, underscoring recent incidents linked to transvaginal mesh and breast implants.
The agency said it will develop and soon publish on its website a separate document with more detailed information on each strategy of the action plan, including proposed consultations, actions and activities.
The new strategies are intended to further strengthen confidence in the Australian regulatory system for medical devices. They follow recent media reports that underscored certain weaknesses in existing regulations not just in Australia, but also in Canada, the US and Europe.
The 2018 International Consortium of Investigative Journalists (ICIJ) investigation into patient harm associated with surgically implanted medical devices, including spinal implants and transvaginal mesh, sparked efforts for medical device regulatory reform across multiple countries. TGA now joins Health Canada, which issued
a medical device action plan of its own last December.
The US Food and Drug Administration (FDA) updated
its April 2018 medical device safety action plan last November. Greater transparency is a cornerstone of the action plans from TGA, Health Canada and FDA—all of which are members of the International Medical Devices Regulators Forum.
An Action Plan for Medical Devices