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Presentation: Session 1: Post-market roles and responsibilities of sponsors

Workshop: Medical devices: how to stay included

24 August 2016


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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: Sharon Bennett
  • Presented at: Workshop: Medical devices: how to stay included
  • Presentation date: Workshops were held on 19 May 2016, 2 June 2016, 23-24 June 2016, 21 July 2016 and 27 July 2016
  • Presentation summary: This presentation discusses the post-market roles and responsibilities of sponsors for a medical device.


Medical Devices: how to stay included

Post-market roles and responsibilities of sponsors

Sharon Bennett
IRIS Coordinator
Medical Devices Branch, TGA

Medical Devices: how to stay included Workshop

Slide 1 - Learning outcomes

It is envisaged at the end of this session you will be able to:

  • Recognise the role of the TGA in post-market vigilance and monitoring
  • ecognise the role of the sponsor in post-market vigilance and monitoring
  • Comprehend compliance with mandatory legislation and how it relates to the sponsor's role in post-market vigilance and monitoring

Slide 2 - Overview

  • The TGA's Role in post-market vigilance and monitoring
  • Post-market regulation
  • Mandatory requirements (legislative)
  • On-going monitoring/Compliance by TGA

Slide 3 - Role of the TGA in market vigilance and monitoring

The TGA's role is to continually monitor and evaluate the safety and efficacy or performance of the therapeutic goods that are available on the market and to manage any risk associated with individual products

TGA's market vigilance and monitoring including assessing evidence, register, enforce compliance, monitor and changes to product information, safety alerts and recalls

We regulate therapeutic goods throughout their lifecycle in a number of ways

  • Register
  • Monitor
  • Changes to product information, safety alerts, recalls
  • Enforce compliance
  • Assess evidence

Slide 4 - Regulation of medical devices

  • Post-market regulation of devices is monitoring to ensure the device continues to be "free from unacceptable risk"
  • At all times the supplier and manufacturer must demonstrate continued compliance with the Essential Principles that describe the safety and performance of a medical device

Slide 5 - Device safety monitoring

Three major components of device safety monitoring:

  1. Ensure that the manufacturer complies with the TGA's required post-market surveillance system
  2. Vigilance programs, such as incident reporting
  3. The TGA monitors and regulates devices throughout their life cycle

Slide 6 - The TGA has authority to...

  • Ask questions of sponsors and manufacturers. There are penalties for providing false and misleading information
  • Seize products and inspect premises
  • Cancel/suspend products from supply
  • Mandate a recall of a therapeutic product

Manufacturer/Sponsor is obliged to gather and report certain information

Slide 7 - Risk-based approach to regulation

  • The Act outlines a risk based regulatory framework for therapeutic goods
  • The benefits of any product should outweigh the risks associated with its use
  • The role of the TGA is to regulate therapeutic products based on a scientific and clinical assessment of the evidence of both the risks and the benefits of those products
  • The TGA uses this same risk-based approach in both its monitoring and compliance activities

Slide 8 - Different sources of risks

  • Product risks (risks that are inherent to the product)
  • Compliance risks (risks occurring from products failing to meet requirements)
  • Unlawful products (risks of unauthorised products)

Slide 9 - On-going monitoring by TGA

Monitoring programs → Signal detection methods → Signal review procedures → Actions proportionate to risk

  • Undertaken to ensure that regulatory compliance and safety of the medical devices continues after supply to the Australian market.
  • Determination of the significance of any signals detected and the appropriate regulatory response.

Cycle Diagram - Monitoring programs - signal detection methods - signal review procedures - actions proportionate to risk

Slide 10 - On-going monitoring by TGA

Monitoring activities may include:

  • Review/investigations of adverse event reports
  • Trend analysis and reporting to sponsors
  • Reviews of technical and clinical information to ensure that compliance with the Essential Principles and conformity assessment procedures is demonstrated
  • Testing to confirm compliance with the Essential Principles
  • Inspections of manufacturer or sponsor's records and documentation

Slide 11 - On-going compliance by TGA

The TGA may take corrective action in accordance with the legislation if problems are found, such as:

  • sponsors and/or manufacturers not fulfilling their regulatory responsibilities
  • safety concerns about a medical device
  • certifications made in the device application are incorrect or no longer correct

Slide 12 - TGA's approach to compliance

← Low compliance risk High compliance risk →
TGA's approach to compliance

Help and support

  • Make ongoing compliance easy

Inform and advise

  • Help to become and stay compliant

Correct behaviour

  • Deter by detection


Regulated entity - attitude to compliance

Voluntary compliance

  • Effective compliance systems
  • Management is compliance oriented

Accidental non-compliance

  • Ineffective and/or developing compliance systems
  • Management compliance oriented but lacks capability

Opportunistic non-compliance

  • Resistance to compliance
  • Limited or poor compliance systems
  • Management not compliance oriented

Intentional non-compliance

  • Deliberate non-compliance
  • No compliance systems
  • Criminal intent
'Committed to doing the right thing' 'Trying to do the right thing but don't always succeed' 'Don't want to comply but will if made to' 'Decision to be non-compliant'

Slide 13 - On-going compliance by TGA

Possible actions

  • consultation with expert advisory committees
  • disseminating information and/or oversees corrective actions (e.g. safety alerts, product or labelling changes)
  • exchanging information with other regulatory agencies
  • cancel/suspend products from supply
  • recall of a therapeutic product

Slide 14 - Mandatory requirements (legislative)

Section 41FD of the Therapeutic Goods Act 1989 - matters to be certified

Summarising this section of the Act, this is what the sponsor has done to include their device on the ARTG

  • Essential Principles
  • Conformity assessment
  • The intended purpose, and
  • The acknowledgement that the sponsor has the information readily available to substantiate the claims made in including their device on the ARTG

Slide 15 - Mandatory requirements (legislative)

Section 41FN - Conditions applying automatically

Summary of the relevant points for this workshop are below:

  • availability of information
  • report details of certain incidents and performance issues to the TGA
  • report results of investigations undertaken by the manufacturer to the TGA
  • assist the TGA and the manufacturer in investigations if an incident occurs
  • maintain distribution records for product supplied in or exported from Australia
  • deliver samples upon request
  • For the others please go to pg 296 for the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Slide 16 - Mandatory requirements (legislative)

41JA - Secretary may require information

  • The TGA may request information about the device under this section of the Act
  • The TGA can require you to supply information/documents on compliance with the Essential Principles or supply numbers.
  • Important points to remember when responding to a 41JA letter;
    • The date you must respond by,
    • Ensuring all the relevant information is supplied,
    • If unsure clarify early.

Slide 17 - Mandatory requirements (legislative)

41GA - Suspension of kinds of medical devices from the Register

The TGA may suspend the kind of device from the Register on the following grounds;

  • There is a potential risk of death, serious illness or serious injury if the kind of device continues to be included in the Register, and
  • it is likely that the person will, within the period of the suspension, be able to take the action necessary to ensure that the kind of device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register

A notice to suspend always gives a time period for the suspension not exceeding 6 months

Slide 18 - Mandatory requirements (legislative)

41GN Cancellation of entries of kinds of medical devices from the Register after notice of proposed cancellation

The TGA may send a Proposal to Cancel or a Cancellation letter for the following reasons:

  • Devices of that kind have changed so those medical devices are no longer devices of that kind
  • Refusal or failure to comply with a condition to which that inclusion is subject to
  • Non compliance with a 41JA request for information
  • The person contravenes subsection 41MP(1) or 41MPA(1) in relation to the kind of device
  • The safety or performance of the device is unacceptable
  • Certification, or part of a certification, under section 41FD is incorrect, or is no longer correct.

A cancellation does not take place until the opportunity to provide information under the Proposal to Cancel is considered

Slide 19 - Mandatory requirements (legislative)

Therapeutic Goods Act 1989: 41C - Essential Principles

The Essential Principles set out the requirements relating to the safety and performance characteristics of medical devices. For a device to be supplied in Australia it must be demonstrated that it has met the Essential Principles. The Essential Principles can be found in detail in the;

Therapeutic Goods (Medical Devices) Regulations 2002 ~ Schedule 1: Essential Principles

It is the manufacturer's responsibility to demonstrate compliance with the Essential Principles for their medical devices

Slide 20 - At the end of the post-market roles and responsibilities session it is envisaged that the sponsor will be able to:

  • Recognise the role of the TGA in post-market vigilance and monitoring
  • Recognise the role of the sponsor in post-market vigilance and monitoring
  • Comprehend compliance with mandatory legislation and how it relates to the sponsor's role in post-market vigilance and monitoring

Slide 21 - Further Information

Relevant documentation:

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