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How the TGA regulates software based medical devices

Guidance

This guidance summarises the regulatory approach of the TGA for software based medical devices.

Last updated

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

Supporting documents

Topics

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