Proposed Enhancements to Adverse Event Reporting for Medical Devices - Industry

Closes 2 Dec 2020

Consultation contents

Start here by reading the TGA's consultation paper 'Proposed Enhancements to Adverse Event Reporting for Medical Devices'.

You may answer all or selective questions. Only the ‘Publishing Your Response’ section is mandatory - this must be completed in order to submit a response (HINT: it is the only section with a 'Finish' button at the end).

Each section will include the relevant attachment from the consultation paper, for your reference. Once you have completed a section (or as many questions as you want to answer) click the 'Continue' button at the bottom of the page. Doing so will return you to the current page (titled 'Consultation Contents') where you can select another section of questions to answer.

The survey is divided into sections that relate to each proposal, as numbered in the consultation paper. For example:

Proposal 1 - make changes to the current adverse event reporting exemptions

Proposal 2 - strengthen reporting requirements for medical device adverse events etc.

Proposal 5 looks at reviewing the accessibility and usefulness of the safety information provided by the TGA to the consumers of the medical devices. The survey is primarily seeking feedback from consumers of medical devices. However, members of the medical device industry (such as sponsors and manufacturers) are also welcome to provide their feedback.

You will find a list of questions about yourself under the section titled 'Respondent Information'. The questions in this section are not mandatory and can be skipped. Telling us more about you and your interest in this subject, allows us to better understand your unique needs and perspective.

Thank you very much for your feedback - we look forward to learning more about your issues and ideas about the proposed changes.

Page Response
Privacy and Personal Information This page has no questions
Respondent Information
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0 of 9 questions answered
Introduction and Background This page has no questions
Proposal 1 - Make changes to the current adverse event reporting exemptions
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0 of 11 questions answered
Proposal 2 - Strengthen reporting requirements for medical device adverse events
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0 of 7 questions answered
Proposal 3 - Implement a program of TGA inspections and audits of sponsor activities and premises
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0 of 6 questions answered
Proposal 4: Review post-market definitions in the Medical Device Regulations
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0 of 2 questions answered
Proposal 5: Find ways to enhance communication between the TGA and the consumers of medical devices
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0 of 24 questions answered
Summary
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0 of 1 questions answered
Publishing Your Response (Required)
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0 of 5 questions answered