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Consultation: Software as a Medical Device (SaMD): Clinical Evaluation

2 November 2016

This consultation closed on 2 December 2016

Invitation to comment

The International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD) Working Group seeks to develop guidance that supports innovation and timely access to safe and effective SaMD globally.

The group is currently developing guidance for the clinical evaluation of (and evidence for) SaMD, and released the following proposed guidance for public comment:

The TGA (together with all other working group members) invited interested parties to comment on the document.

Deadline for submissions

Interested parties should respond by close of business Friday 2 December 2016 (U.S. Eastern Standard time).

What will happen

Submissions will be reviewed by the IMDRF working group and feedback will be released on the IMDRF website.

After consideration of the public comments, a new proposed document will be developed and, pending approval by the IMDRF Management Committee, the updated document will be published.



The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world (including the TGA) who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and aims to accelerate international medical device regulatory harmonisation and convergence.

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 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. To date, the working group has published three documents on Software as a Medical Device.

The objective of the current document is to provide detailed guidance and clarify when (and to what level) clinical evaluation and evidence is necessary or acceptable for SaMD from a patient safety perspective, with particular emphasis on SaMD with diagnostic functionality.

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.

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'.