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Consultation: Software as a medical device (IMDRF working group)

12 May 2014

This consultation closed on 31 May 2014.

The IMDRF Standalone Medical Device Software Harmonisation working group has published a possible regulatory risk categorisation and control framework relating to software as a medical device (SaMD). The TGA (together with all other working group members) invited interested parties to comment on the document.

These documents are available in pdf and word format from the IMDRF website at: Software as a medical device: Possible framework for risk categorization and corresponding controls.


Interested parties should respond by close of business on Saturday 31 May 2014.

Feedback will be released on the IMDRF website towards the end of 2014. (see 'What will happen').

About the consultation

Software is becoming increasingly important in medical devices; however, its rapid evolution, particularly in relation to mobile technology, presents new and complex challenges. Internationally, regulatory agencies are closely monitoring developments in medical software that might be used in diagnostic tools and other medical devices. The IMDRF Standalone Medical Device Software Harmonisation (SaMD) working group was established to address the unique risks and regulatory challenges associated with medical device software. The working group has members from regulatory bodies in Japan, the EU, the USA, Australia, South America, and Canada.

The working group is inviting comment on a possible risk categorisation and control framework for SaMD. Submissions made during the consultation will contribute to the development of a converged regulatory framework structured to address the potential public health risks posed by software as a medical device.

Please note that submissions should be made to the chair of the working group rather than directly to the TGA.


About the International Medical Devices Regulators' Forum

The International Medical Devices Regulators' Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to accelerate international medical device regulatory harmonisation and convergence. The organisation includes representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, the European Union, Japan, and the United States.

Further information about the IMDRF is available on the official website: IMDRF.

About software as a medical device

The term software as a medical device refers to software supplied independently of any specific hardware. Examples of SaMD include:

  • Smart-phone apps used for diagnosis of medical conditions
  • X-ray image-processing software intended to run on a PC
  • IVD diagnostic software

Further information about the regulation of (all) medical device software in Australia is available on the web page: Regulation of medical software and mobile medical 'apps'.


Any and all comments on the risk framework document are welcome. Some suggestions (by no means prescriptive) for comments include:

  • whether or not you support the premise of the framework;
  • aspects of risk categorisation (technical or otherwise) and corresponding controls that you feel are not adequately addressed by the framework;
  • controls that can be used to assure the quality of software produced;
  • any limitations or suggestions about the framework you would like to make;
  • potential flaws with any assumptions made in the framework;
  • aspects of the framework that you support or do not support (ideally with an explanation of why); and
  • an assessment of how the framework might affect you, your organisation, or specific healthcare sectors.

What will happen

Submissions will be reviewed by the IMDRF working group and a new proposed document will be developed and published after consideration of the public comments. The updated document will be published on the IMDRF website towards the end of 2014.


Please send enquiries to the IMDRF SaMD Working Group Chair, Mr Bakul Patel at

TGA-specific enquires may be made to