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How the TGA regulates software based medical devices

24 February 2021
Download How the TGA regulates software based medical devices

Description

This guidance summarises the regulatory approach of the Therapeutic Goods Administration (TGA) for software based medical devices.

  • About this guidance
  • TGA regulation of software products
  • Key regulations
  • What to consider
  • Where to find more information
  • Definitions
  • Classification Rules
  • Essential Principles
  • Conformity Assessment Procedures

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