Medical devices: how to stay included Post-market roles and - - PowerPoint PPT Presentation

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medical devices how to stay included
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Medical devices: how to stay included Post-market roles and - - PowerPoint PPT Presentation

Dec 01, 2023 483 likes •728 views

Medical devices: how to stay included Post-market roles and responsibilities of sponsors Sharon Bennett IRIS Coordinator Medical Devices Branch Therapeutic Goods Administration Learning outcomes It is envisaged at the end of this session you

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Medical devices: how to stay included

Post-market roles and responsibilities of sponsors

Sharon Bennett IRIS Coordinator Medical Devices Branch Therapeutic Goods Administration

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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

  • 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

Post-market roles and responsibilities of sponsors 1

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Overview

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

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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

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Monitor

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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

Post-market roles and responsibilities of sponsors 4

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Device safety monitoring

Three major components of device safety monitoring: Ensure that the manufacturer complies with the TGA’s required post-market surveillance system Vigilance programs, such as incident reporting The TGA monitors and regulates devices throughout their life cycle

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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

TGA

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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

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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)

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On-going monitoring by TGA

  • 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.

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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

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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

Post-market roles and responsibilities of sponsors 11

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TGA's approach to compliance

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

Enforce 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
  • riented but lacks capability

Opportunistic non- compliance

  • Resistance to compliance
  • Limited or poor compliance

systems

  • Management not compliance
  • riented

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’

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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

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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

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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).

https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd

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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.

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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

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Mandatory requirements (legislative)

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

  • f 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

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Mandatory requirements (legislative)

Therapeutic Goods Act 1989: 41C - Essential Principles Therapeutic Goods (Medical Devices) Regulations 2002 ~ Schedule 1: 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; It is the manufacturer’s responsibility to demonstrate compliance with the Essential Principles for their medical devices

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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

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Further Information

Relevant documentation:

  • Therapeutic Goods Act 1989
  • Therapeutic Goods (Medical Devices) Regulations 2002
  • Therapeutic Goods Regulations 1990

https://www.tga.gov.au/legislation-legislative-instruments

  • Australian regulatory guidelines for medical devices (ARGMD)

https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices- argmd

  • https://www.tga.gov.au/sites/default/files/devices-argmd-01.pdf

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