Therapeutic Goods Administration (TGA) Australia has published the finalised guidance document on regulatory changes for software-based medical devices in August 2021.
The guidance provides a summary of changes to the regulation of software-based medical devices (including software as a medical device – SaMD) which commenced on 25 February 2021. It outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.
The Therapeutic Goods (Medical Devices) Regulations 2002 were amended by the Government to clarify some existing requirements and to introduce new requirements for software-based medical devices.
The changes, which commenced on 25 February 2021, include:
Clarifying the boundary of regulated software products (including ‘carve outs’)
- Certain software-based medical devices were carved out (through either an exemption or exclusion) from the scope of the TGA regulation.
Introducing new classification rules
- All new applications will need to meet the new classification rules from 25 February 2021, with a transition period ending 1 November 2024.
Providing updates to the essential principles to express the requirements more clearly for software-based medical devices
- Essential Principle 13.2(3) is amended to allow information to be provided electronically rather than on a leaflet.
- A new essential principle, Essential Principle 13B, will be introduced requiring the current version and build number for the software to be made accessible and identifiable to users of software-based medical devices. This information must be in English, however may also be displayed in other languages.
More details can be found in “Regulatory changes for software-based medical devices”, August 2021: https://www.tga.gov.au/resource/regulatory-changes-software-based-medical-devices