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TGA presentation: How the TGA regulates software, 7 March 2019

Webinar presentation: Regulation of software, including software as a medical device

8 May 2019


These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.


  • Presented by: Dr Elizabeth McGrath
  • Presented at: Online
  • Presentation date: 7 March 2019
  • Presentation summary: This webinar discusses how the current regulatory scheme applies to software.


Regulation of software, including software as a medical device

Dr Elizabeth McGrath
Director, Emerging Technologies
Dr Lee Walsh CPEng (Presenter)
Technical Lead, Digital Health
Medical Devices and Product Quality Division

Webinar presentation: Regulation of software, including software as a medical device, 7 March 2019

Slide 1 - Housekeeping

  • Today's event will be recorded
  • To participate: type your question in the bottom left message box
  • Messages are privatised to moderator and speakers only
  • We will be conducting live polls throughout this event
  • Difficulties hearing sound from your computer? please feel free to listen to the event via your telephone:
    • Dial 1800 896 323
    • Enter Pass Code 133 024 7191
    • If difficulties still continue please contact Redback services for support on 1800 733 416
  • This event will be published on the TGA website
    • News room
    • Presentations

Slide 2

  • Medical Device Regulation for Market Authorisation
  • Considerations for Software
  • International Approaches and Australian Regulatory Reforms
  • Questions

Slide 3 - Medical Device Regulation for Market Authorisation

Slide 4 - The benefit versus risk approach

  • No therapeutic good is risk free
  • The work of the TGA is based on applying scientific and clinical expertise to decision making
  • We ensure that the benefits outweigh any risks

Slide 5 - Medical device legislation

  • Therapeutic Goods Act 1989 (Chapter 4)
    • Therapeutic Goods (Medical Devices) Regulations 2002

Slide 6 - What is a medical device?

Defined in s41BD of the Therapeutic Goods Act 1989

Any instrument, apparatus, appliance, material or other article intended to be used for human beings for the purpose of one or more of the following:

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease;
(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability
(iii) investigation, replacement or modification of the anatomy or of a physiological process
(iv) control of conception; and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means

Slide 7 - What is a manufacturer?

41BG  Manufacturers of medical devices

(1) The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person’s name, whether or not it is the person, or another person acting on the person’s behalf, who carries out those operations.

Slide 8 - Regulatory requirements - 4 Steps

  1. Risk based classification system
    • Classification determines minimum CA procedure(s)
  2. Conformity assessment (CA) procedures
    • Manufacturing requirements
    • Essential principles (EP)
  3. Inclusion in the Australian Register of Therapeutic Goods
  4. Post market monitoring and reporting

Slide 9 - Step 1 - Risk based classification

Risk classification is based on:

  • Potential to Harm patients, users and other persons
  • Degree of invasiveness in the human body
  • Location and Duration of use
  • Intended use of the device

Slide 10 - Regulatory oversight increases with increasing risk category

Regulatory Scrutiny

Regulatory scrutiny class iii 4 ticks class iib 3 ticks classiia 2 ticks classi 1 tick

Slide 11 - Step 2 - Conformity assessment

Requirements for manufacturers

  • Quality Management System
    • Quality management system in compliance with ISO 13485 (except for Class I devices)
  • Technical documentation
    • Technical documentation for the design of the device including evidence of testing
  • Declaration of Conformity
    • Declaration that the device complies with the regulatory requirements
  • Post market surveillance
    • Surveillance of product performance in the market

Slide 12 - The essential principles

Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 1

General principles

  1. Use of medical devices not to compromise health and safety
  2. Design and construction of medical devices to conform to safety principles
  3. Medical devices to be suitable for intended purpose
  4. Long-term safety
  5. Medical devices not to be adversely affected by transport or storage
  6. Benefits of medical devices to outweigh any side effects

Principles about design and construction

  1. Chemical, physical and biological properties
  2. Infection and microbial contamination
  3. Construction and environmental properties
  4. Medical devices with a measuring function
  5. Protection against radiation
  6. Medical devices connected to or equipped with an energy source
  7. Information to be provided with medical devices
  8. Clinical evidence
  9. Principles applying to IVD medical devices only

Federal Register of Legislation

Slide 13 - What is clinical evidence for a medical device?

Clinical evidence guidelines: Medical devices

Slide 14 - Step 3 - Inclusion in the ARTG

Evidence Requirements

  • Class I Self-assessment and declaration
  • Class Is, Im, IIa
    • Manufacturing certification including technical file review
  • Class IIb
    • Manufacturing certification including technical file review
    • Mandatory application audit for some Class IIb devices
  • Class III
    • Manufacturing certification
    • Device design examination certification
  • Mandatory application audit

Slide 15 - Step 4 - Postmarket obligations

  • For higher risk devices: an AIMD, Class III or implantable Class IIb device.
    • Three consecutive annual reports to the TGA required
  • Monitoring of product performance
    • Adverse event reporting to the TGA
  • Environmental scanning
    • Review of medical & scientific literature, regulatory news, media and other sources

Slide 16 - Some exceptions

The following are not required to be in the ARTG:

  • Special Access Scheme for Unapproved Goods
  • Experimental Product Exemptions
  • Custom Made Medical Devices
  • In-House In Vitro Diagnostic Devices

Slide 17 - Australian clinical trial handbook

Australian clinical trial handbook

Clinical Trials

  • CTN
  • CTX
  • HREC
  • HREC
  • Notification to TGA
  • Approval by TGA

Slide 18 - Considerations for Software

Slide 19 - Is it regulated?

Software is regulated by the TGA

  • When it is part of a hardware medical device or medical device system
  • When it controls a medical device
  • When it meets the definition of a medical device.

That is, when the legal manufacturer intends for the software to be used for:

  • diagnosis
  • prevention
  • monitoring
  • treatment, or
  • alleviation, of disease, injury or disability

Slide 20 - Software as a Medical Device (SaMD)

Software that is intended to run on general purpose computing platforms and is also a medical device1

  • Platforms could include computers, tablets, phones, web browsers
  • Examples:
    • Image processing for diagnosis or pathology
    • Software that collects information and makes a clinical decision or referral
    • Apps that calculate drug dose

1As defined in 41BD of the Therapeutic Goods Act 1989.

Slide 21 - Software as a Medical Device (SaMD)

Does not include:

  • general health and lifestyle apps (not a MD)
  • software that is part of a device (not regulated separately)
  • apps that control a medical device (accessory and MD)
  • apps that rely on hardware in addition to a general purpose computing platform, eg – sensors, to achieve their intended purpose

Slide 22 - Classification rules for software

4.1 Active medical devices - general

An active medical device is classified as Class I, unless the device is classified at a higher level under another clause in this Part or in Part 2, 3 or 5.

Regulation 3.3

(5) If a medical device is driven, or influenced, by an item of software, the software has the same classification as the medical device.

Most software is Class I under the current rules

Slide 23 - Evidence of compliance

  • QMS
  • Version control
  • Release management
  • Design validation
  • Bug/issue reporting and correction
  • Clinical evidence
  • Benefit must outweigh the risks

Document it

Slide 24 - Evidence of compliance

Important standards

ISO 13485 - Medical devices - Quality management systems - Requirement for regulatory purposes

ISO 14971 - Medical devices - Application of risk management to medical devices

IEC 62304 - Medical device software - Software life cycle processes

Slide 25 - What is clinical evidence for a software medical device?

Slide 26 - International approaches and Australian regulatory reforms

Slide 27 - Differences in regulatory schemes

Jurisdiction Self Assessed Premarket Product Assessment Premarket Manufacturer Assessment Premarket Manufacturer Certification Premarket Product Certification
Australia, Europe, FDA Class I
Australia and Europe Class IIa, IIb
FDA Class II
Australia and Europe Class III

Slide 28 - Differences in regulatory schemes

Recent Regulatory Reforms

  • Europe
    • Higher Classification for Software that provides information for clinical decision making
  • FDA
    • Premarket assessment and certification of manufacturers for software products
  • Australia
    • Current consultation for higher classification for software for clinical decision making, therapy

Slide 29 - New requirements in Europe

  • The EU MDR 2017/745 has introduced the following new classifications for software:
  • Software that provides information to be used in making decisions for diagnosis or treatment is:
    • Class III if the decisions have an impact that may cause death or an irreversible deterioration of a person's state of health
    • Class IIb if the decisions have an impact that may cause a serious deterioration of a person's state of health or a surgical intervention
    • Class IIa in any other case

NOTE: The EU already has an additional classification rule applicable to software compared with Australia:
Rule 16 (MDD 93/42/EEC)
Devices specifically intended for recording of X-ray diagnostic images are in Class IIa.

Slide 30 - New Requirements in the USA

Digital Health Software Precertification (Pre-Cert) Program

Slide 31 - Proposed new requirements in Australia

  • New rules to appropriately classify SaMD products according to the potential harm they could cause to patients
  • Exclude SaMD products from the personal importation provisions so that SaMD products will be required to be included in the ARTG and have an Australian sponsor
  • Ensure the essential principles for medical devices include clear and transparent requirements for demonstrating the safety and performance of SaMD and other regulated software.

Slide 32 - Website references and contacts

Medical device regulation basics

Regulation of Software as a Medical Device (SaMD)

Premarket medical device enquiries

The TGA's Digital Devices team

Slide 33 - For more on TGA visit

Slide 34 - Questions

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