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

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 Post-market roles and responsibilities of sponsors 1

Overview • The TGA’s Role in post-market vigilance and monitoring • Post-market regulation • Mandatory requirements (legislative) • On-going monitoring/Compliance by TGA Post-market roles and responsibilities of sponsors 2

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 Monitor individual products 3 Post-market roles and responsibilities of sponsors

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

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 5 Post-market roles and responsibilities of sponsors

The TGA has authority to… • Ask questions of sponsors and manufacturers. There are penalties TGA 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 Post-market roles and responsibilities of sponsors 6

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) Post-market roles and responsibilities of sponsors 8

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. Post-market roles and responsibilities of sponsors 9

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 Post-market roles and responsibilities of sponsors 10

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

TGA's approach to compliance TGA's approach to compliance Help and support Inform and advise Correct behaviour Enforce •Make ongoing •Help to become and stay •Deter by detection compliance easy compliant Regulated entity - attitude to compliance Voluntary Accidental non-compliance Opportunistic non- Intentional non- compliance •Ineffective and/or developing compliance compliance •Effective compliance compliance systems •Resistance to compliance •Deliberate non- systems •Management compliance •Limited or poor compliance compliance •Management is oriented but lacks capability systems •No compliance compliance oriented •Management not compliance systems oriented •Criminal intent ‘Committed to doing ‘Trying to do the right thing ‘Don't want to comply but will ‘Decision to be non- the right thing’ but don't always succeed’ if made to’ compliant’ 12

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 Post-market roles and responsibilities of sponsors 13

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 Post-market roles and responsibilities of sponsors 14

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 Post-market roles and responsibilities of sponsors 15

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. Post-market roles and responsibilities of sponsors 16

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 Post-market roles and responsibilities of sponsors 17

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 Post-market roles and responsibilities of sponsors 18