Medical devices: how to stay included · • sponsors and/or manufacturers not fulfilling their...
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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
Transcript of Medical devices: how to stay included · • sponsors and/or manufacturers not fulfilling their...
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 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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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
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
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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 Post-market roles and responsibilities of sponsors 7
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
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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 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’
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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 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
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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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