TGA Software Guidance: Regulations and Exclusions

There was a new guidance released by The Australian Therapeutic Goods Administration (TGA) which aims to assist sponsors, manufacturers, and software developers to clarify what software is and is not regulated by the TGA. There are 15 exclusions and 1 exemption for specific types of software products. Excluded products are completely unregulated by TGA, and do not need to be included in the ARTG (Australian Register of Therapeutic Goods).

For more information about the TGA software guidance, please refer to:

• • https://www.legislation.gov.au/F2018L01350/latest/text
  • https://www.tga.gov.au/regulation-software-based-medical-devices

Groups excluded from the TGA software guidance include:

• • Consumer health life-cycle prevention, management and follow up
  • Enabling technology for telehealth, remote diagnosis, and healthcare facility management
  • Digital mental health tools
  • Digitization of paper-based other published clinical rules or data
  • Population-based analytics
  •  Laboratory information management systems and laboratory information systems.

An exemption has also been introduced for some clinical decision support system (CDSS) software. 

Exclusions include:

• • Consumer health products
  • Digital mental health tools
  • Enabling technology for telehealth or supporting healthcare delivery  
  • Middleware
  • Digitization of paper-based data or other published clinical rules,
  • Population based analytics
  • Laboratory information management systems (LIMS) and Laboratory information systems (LIS).

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If you need help understanding the TGA’s latest update for software guidance or classifying if your SaMD is exempt from the latest guidance, don’t hesitate to contact us so our expert regulatory team can assist you. 

Learn how MedEnvoy can help you:

• • Australian TGA Sponsor
  • RA Consulting
  • QA Consulting