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Consultation: Software as a Medical Device (IMDRF Working Group)
This consultation closed on 27 May 2015
Invitation to comment
A proposed document-Software as a Medical Device (SaMD): Application of Quality Management System-has been released by the International Medical Device Regulators Forum (IMDRF) for public comment.
- Software as a Medical Device (SaMD): Application of Quality Management System (pdf, 270kb)
- Software as a Medical Device (SaMD): Application of Quality Management System (docx, 526kb)
The TGA (together with all other working group members) is inviting interested parties to comment on the document.
Interested parties should respond by close of business Wednesday 27 May 2015.
Feedback will be released on the IMDRF website towards the end of 2015. (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.
To date, the working group has published two documents on Software as a Medical Device:
- Software as a Medical Device (SaMD): Key Definitions (pdf,119kb)
- Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations (pdf,243kb)
The objective of this third document is to provide guidance on the application of existing, standardised, and generally accepted quality management system (QMS) practices to SaMD. It starts from the perspective of a software development organisation (of any size, i.e., could range from a one person enterprise up to a multi-national corporation) that incorporates the activities of a QMS and quality practices relevant to software development. The document gives an overview of these software quality activities and reinforces medical device quality principles that should be appropriately incorporated for an effective SaMD QMS.
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 refer to the 'How to respond' section below).
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, Russia, 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'.
Content of submissions
Any and all comments on the application of QMS to Software as a Medical Device document are welcome. Some suggestions (by no means prescriptive) for comments include:
- the underpinning premise, assumptions, or limitations of the guidance;
- any aspects missing, or not adequately addressed, or other suggestions about the details of the guidance;
- an assessment of how the guidance might affect you, your organisation, or specific healthcare sectors;
- whether there is a need for including further details relating to QMS principles or software life cycle activities; and
- whether there is a need for further details about good software-engineering practice or software risk management.
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. Pending approval by the IMDRF Management Committee, the updated document will be published on the IMDRF website towards the end of 2015.
- The TGA collects your personal information in this submission in order to:
- contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- help provide context about your submission (e.g., to determine whether you are an individual or a director of a company or representing an interest group).
- Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
Please send enquiries to the IMDRF SaMD Working Group Chair, Mr Bakul Patel at firstname.lastname@example.org.
TGA-specific enquires may be made to Software.Regulation@tga.gov.au.