TGA releases new regulations for software-based medical devices

The Therapeutics Good Administration (TGA) released guidance to help medical software manufacturers understand the criteria for the qualification of software under the the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations), amended on 12 December 2019.

Software as a medical device (SaMD)

Medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the software is independent or driving or influencing the use of a device.

What’s changing

The Regulations have been amended in relation to software-based medical devices including programmed and programmable hardware (referred to collectively as ‘programmed or programmable medical device, or software that is a medical device’):

• New classification rules have been introduced to classify devices of this kind according to their potential to cause harm through the provision of incorrect information.
  1. The rules are largely aligned with the software rules in the EU MDR 2017
  2. In some cases, a device will be a lower classification (where a relevant healthcare professional is involved);
  3. Devices that provide direct diagnosis or monitoring will be the same class in most cases.
  4. Devices intended to provide therapy via the provision of information (e.g., a medical device intended to provide cognitive behavioural therapy) will potentially be a higher class in some cases.
  5. The new classification rules will not apply to in vitro diagnostic (IVD) medical devices.

• Essential principle 12.1 has been amended to clarify the expectations around these types of devices, including with regards to cyber security; the management of data and information; and requirements relating to development, production, and maintenance.
• Essential Principle 13.2(3) has been amended to allow information, where applicable, to be provided electronically rather than on a leaflet for medical devices that are software.
• A new requirement has been introduced, as Essential Principle 13B, for identification of current version and build number to be made accessible by, and identifiable to, users of medical devices that are, or that incorporate, software. 

Further guidance will be provided in early 2020.

Important dates

The new software regulations will commence on 25 August 2020 for new applications for inclusion.

Transitional arrangements for medical devices that are included in the ARTG on this date will apply.

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