Proposed regulatory changes for clinical trials of medical devices

Closed 28 Sep 2022

Opened 17 Aug 2022

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on proposed regulatory changes to strengthen safety oversight of clinical trials for medical devices. The changes are: 

  1. To increase the degree of regulatory oversight of clinical trials of certain unapproved, high-risk medical devices.
  2. To include clinical trials of all medical devices in Australia’s Good Clinical Practice Inspection Program (to enable selected trials and documentation supporting these trials to be inspected).

https://www.tga.gov.au/consultation/consultation-proposed-regulatory-changes-clinical-trials-medical-devices

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