You are here

Is my software regulated?

24 February 2021
Download Is my software regulated?

Description

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?

We aim to provide documents in an accessible format. If you are having problems using a document with your accessibility tools, please contact us for help.