Dive Brief:

• Australia’s Therapeutic Goods Administration unveiled Thursday a three-pronged proposal aimed at boosting the country’s oversight of medical devices, more tightly regulating how medical devices enter the Australian market, strengthening postmarket monitoring and publishing more information on how decisions are made for higher risk devices.
• The actions, sparked in part by a highly critical series of reports taking aim at global oversight of devices by the International Consortium of Investigative Journalists, will be implemented during 2019 and early 2020, according to TGA.
• Other proposals include raising the bar for medium and high risk device approvals and beefing up clinical trial requirements.

Dive Insight:

TGA’s action plan identifies initiatives already in the works, lays out additional steps to improve transparency and seeks feedback on new ways to increase public confidence in its oversight of medical devices.

Currently, low-risk devices can be self-certified by a manufacturer to enter the Australian market, while riskier devices must be assessed by a qualified body. Certain medium-risk devices may have to be evaluated by TGA while high-risk devices must be reviewed by TGA or "subjected to a detailed audit" before entering the market.

Under the new action plan, Australia is proposing examining if industry self-certification for low-risk devices is appropriate, as well as creating a specialist unit to evaluate new technologies such as 3D printing and software applications and working to provide clearer cybersecurity guidance to industry.

In addition, the administration is asking stakeholders if mandatory TGA audits should be required for medium-risk devices. It also plans to examine how clinical trials supporting approval of a medical device relate to the actual use of the product in the real world.

Further, TGA is considering mandating greater clinical evidence for certain high-risk devices.

"These devices include spinal implants, devices that make diagnoses, diabetes management devices, medical devices used for IVF, and companion diagnostics," TGA said.

Tracking medical device adverse event reports more quickly is also a priority. TGA said it will be working with healthcare systems to more rapidly share information and may require facilities to report safety problems with medicine and medical devices, remove exemptions that make it easier to delay submitting adverse event reports and seek additional authority on recalling devices.

TGA is weighing an increase in inspections of manufacturers as well as a unique device identifier requirement for medical devices to better track individual devices in patients.

"After consultation with stakeholders, the TGA will assess options to increase its inspection program of medical device manufacturing sites to confirm ongoing quality in manufacturing medical devices," regulators said. "Increasing the frequency of manufacturer inspections of certain high risk devices and new onsite auditing of their reporting of adverse events will also be explored."

The introduction of such a plan lags follows FDA's Medical Device Safety Action Plan, released last April, and Health Canada's Action Plan on Medical Devices, put out in December.