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Presentation: Clinical evidence requirement of 'Software as a Medical Device' (SaMD)

TGA presentations: Innovate Health 2019, 27 June 2019

17 September 2019

Disclaimer

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.

Presentation

  • Presented by: Dr David Hau, Senior Medical Officer, Clinical Section, Medical Devices Branch
  • Presented at: Innovate Health 2019
  • Presentation date: 27 June 2019
  • Presentation summary: An overview of the clinical evidence required to satisfy regulatory requirements for a Software as a Medical Device and how this relates to its intended use.