MIL-OSI Australia: Is my software regulated?


Source: Australian Therapeutic Goods Administration

Flowcharts showing which software products are regulated as a medical device, and those that are not.

  • How do I know if my software is a medical device?
  • What if I need more information?
  • Is my software regulated?
  • Is its purpose likely to be medical?
  • Is it excluded?
  • Is the clinical decision support software exempt?

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