Member feedback sought on mandatory reporting of adverse events

AusBiotech is seeking feedback from Members that may be impacted by potential TGA regulation changes on Mandatory Reporting of Medical Device Adverse Events by Healthcare Facilities in Australia.

The Government is exploring whether it should be mandatory for healthcare facilities to report adverse events with medicines and medical devices to the TGA; and removing some existing exemptions to require more timely and improved reporting of adverse events by industry to the TGA.

In Australia, mandatory adverse event reporting requirements exist only for device manufacturers and sponsors. Healthcare facilities, health professionals, and consumers are strongly encouraged to report adverse events, however, this is voluntary.

A number of reviews have highlighted the need for improving the monitoring of medical devices’ safety and performance once supplied on the market, including how adverse events are reported to the TGA.

Areas of interest include:

· Feasibility of mandatory reporting of medical device adverse events in healthcare facilities

· Included or excluded facilities

· Included or excluded device types

· Reporting logistics and avoiding data duplication

· Quality assurance of systems used, and

· Accountability.

Targeted discussions between the TGA and Australian stakeholders and international regulators occurred in early 2021, and insights and feedback from these have informed its Discussion Paper.

The proposed changes are part of the Government’s broader action plan, launched in 2019, for ensuring timely access to information and strengthening post-market medical device monitoring.

A globally thriving medtech ecosystem means that the number, range, and complexity of medical devices will increase over time. As the national voice of the life sciences industry, including medical technology (devices and diagnostics), AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry.

Members are invited to read the consultation paper here

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