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Medical device adverse event reports - statistics for 2013

The Therapeutic Goods Administration (TGA) is responsible for regulating medical devices in Australia, including monitoring the ongoing safety, performance and quality of devices once they have been included on the Australian Register of Therapeutic Goods (ARTG).

This report from the TGA's Office of Product Review (OPR) includes an overview of the following aspects of post-market monitoring of medical devices in Australia:

  • Medical device adverse event reporting statistics for 2013
  • How the Incident Report and Investigation Scheme works
  • How to report an adverse event involving a medical device
  • Post-market reviews
  • Expert advisory committees
  • Medical Devices Safety Update
  • Product vigilance

Read more here.

Last modified: Wed, 18 Jun 2014 13:23:30 BST