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TGA presentation: TERMIS-AP + ABMC7 2019 Congress, 14-17 October 2019

Safety first! How a risk based, life-cycle approach to medical device design improves patient safety

17 October 2019


These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.


  • Presented by: Dr Kelly Tsang, Assistant Director, Devices Conformity Assessment Section, Medical Devices Branch, Therapeutic Goods Administration (TGA)
  • Presented at: TERMIS + ABMC7 2019
  • Presentation date: 16 October 2019
  • Presentation summary: Despite changes and updates in the compelxity and technologies in medical devices and the way they are utilised in healthcare, the principles of good risk management and design practices can be applied to ensure devices and designed for safety and to meet regulatory requirements.