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Regulatory changes for software based medical devices

In effect from 25 February 2021
9 August 2021
Download Regulatory changes for software based medical devices


This guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device - SaMD) that take effect from 25 February 2021. It outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.

  • About this guidance
  • Excluded or exempt software-based medical devices
  • New classification rules
  • Changes to the Essential Principles
  • Where can I find more information?
  • What if I have further questions?

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