Submission to the Therapeutic Goods Administration in response to the Proposed Enhancements to Adverse Event Reporting for Medical Devices

Penny Gleeson (Author)
Rizzi, M. (Author)

UWA Law School

Activity: Industry and government engagement/consultancy › Submissions to or appearance before a government committee, inquiry or agency

Description

In this Submission we respond, in particular, to the TGA’s invitation to consult on the Adverse Event Consultation. We do so through reference to the Action Plan.

Period	30 Nov 2020
Work for	Therapeutic Goods Administration, Australia
Degree of Recognition	National

Documents & Links

TGA Submission - December 2020 - Final
File: application/pdf, 210 KB
Type: Text

The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. We have issued this consultation as part of the reform program. This consultation paper relates to the proposed enhancements to adverse event reporting and improving communication with the consumers of medical devices.