UDI consultation paper 3: Detailed considerations for implementing the proposed Australian medical device UDI Regulatory Framework

Closes 11 Oct 2022

Contents

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Privacy and your personal information This page has no questions
Respondent details and general information
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Introduction and background This page has no questions
References This page has no questions
Question 1 - If Australia accepts both EU and U.S. compliant labels, what might the impact be?
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Question 2 - What should the phased implementation approach be?
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Question 3 - Scope and exemptions
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Question 4 - Who should provide and maintain the data where there are multiple sponsors for a device?
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Question 5 - Providing and maintaining data over the full life of the device
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Question 6 - Fees and charges
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Question 7 - UDI labelling and supporting documentation
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Question 8 - Global Medical Device Nomenclature
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Question 9 - Regulatory burden
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Question 10 - Adoption and use
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Question 11 - Any other feedback?
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Required - Final step - Publishing my response (Required)
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