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Source: Australian Department of Health

This webinar aims to provide information about a proposal to introduce a new program whereby the TGA would actively inspect and/or audit medical device sponsors’ systems for how they identify, report and manage their post market reporting obligations. The webinar format would include a presentation by the TGA, followed by a question and answer session for participants to raise any queries. This webinar may assist participants in understanding the proposal in order to provide well-informed feedback to the current consultation on enhancing medical device adverse event reporting.

A succession of reviews, parliamentary inquiries, international and national media interest, and stakeholder feedback has raised concerns about post market safety and the regulatory monitoring and vigilance processes of medical devices. While Australian regulatory practices are comparable to other regulators around the world, this consultation seeks feedback on proposals to strengthen them further. Improving Australia’s adverse event reporting system will allow the TGA to take quicker actions where there are safety concerns.

It is a condition of inclusion for a medical device in the ARTG that the TGA may inspect documents like evidence of the relationship between sponsor and manufacturer, supply details, and any adverse event reports, complaints and recalls actions held by the sponsors, including on their premises. However, there is no active or ongoing program in place where inspections of sponsors’ premises are routinely undertaken. This proposal looks at introducing an active routine inspection/audit program for sponsors’ premises, processes and documents, rather than the current reactive process, which is generally triggered by a specific adverse event or complaint.

Who should attend?

Any interested medical device industry stakeholder like (not limited to) sponsors, manufacturers and distributors, and consumers like (not limited to) patients, family members of patients, healthcare facilities and health care professionals who may be directly/indirectly affected by changes to current processes.

When will the webinar take place?

  • Monday 2 Novemeber 2020, 2:00-2:45pm
  • Please register here to attend the webinar