SURVEY: Software based Medical Devices – further resources for stakeholders

Closed 3 Jun 2021

Opened 5 Feb 2021

Overview

From 25 February 2021, a new framework for regulating software as a medical device will commence. The Regulation of software based medical devices details these changes, and additionally the following guidance documents have also been published to assist users understand the various processes relevant to software as a medical device (SaMD):

The Therapeutic Goods Administration (TGA) is conducting an education campaign in order to help stakeholders further understand the new framework and meet the regulatory requirements, in efforts to minimise interruption to the supply of SaMD to Australians.

Why we are consulting

What the TGA would like to know:

  • The areas of the new framework that you would like more information about; and
  • How you would like to receive this information (e.g. factsheets, webinars etc.)

The information gathered from this survey will help us develop material and deliver targeted information about the SaMD framework.

Audiences

  • Anyone from any background

Interests

  • Health technology
  • Medicare
  • Legislation
  • Pharmaceutical benefits
  • Health insurance
  • Rural health services
  • Regulatory policy
  • Women's health
  • Children's health
  • Learning and development