Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation - Therapeutic Goods Administration - Citizen Space

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Navigating the consultation survey

Click on a link below to provide your feedback on questions related to the selected proposal.

Page	Response
Consent to publish & contact details (Required)	percent complete 0 of 6 questions answered
Proposal 1: Adopt new AUS Essential Principles	percent complete 0 of 2 questions answered
Proposal 2: Amend AUS Essential Principles 2 & 4	percent complete 0 of 3 questions answered
Proposal 3: Amend AUS Essential Principle 7 - Chemical, physical and biological properties	percent complete 0 of 2 questions answered
Proposal 4: Amend AUS Essential Principle 8 – Infection and microbial contamination	percent complete 0 of 2 questions answered
Proposal 5: Amend AUS Essential Principles 9 - Construction and environmental properties	percent complete 0 of 2 questions answered
Proposal 6: Amend AUS Essential Principle 11 – Protection against radiation	percent complete 0 of 3 questions answered
Proposal 7: Amend AUS Essential Principle 12 – Medical devices connected to or equipped with an energy source	percent complete 0 of 2 questions answered
Proposal 8: Amend AUS Essential Principle 15 - Principles applying to IVD medical devices only	percent complete 0 of 3 questions answered
Proposal 9: Amend AUS Essential Principle 13.1 (General labelling)	percent complete 0 of 6 questions answered
Proposal 10: Amend AUS Essential Principle 13.3 (General labelling)	percent complete 0 of 2 questions answered
Proposal 11: Amend AUS Essential Principle 13.4(3) Item:1-31 (excluding Item 29)– Instructions for use	percent complete 0 of 2 questions answered
Proposal 12: Amend AUS Essential Principle 13.4(3)29 – IFU information for IVD devices only	percent complete 0 of 3 questions answered
Proposal 13: Amend AUS Essential Principle 13B	percent complete 0 of 2 questions answered
Proposal 14: Amend AUS Regulation 10.2 - Australian Sponsors	percent complete 0 of 2 questions answered
Proposal 15: Adopt definitions	percent complete 0 of 2 questions answered
Proposal 16: Transitional arrangements	percent complete 0 of 3 questions answered
Open comments	percent complete 0 of 1 questions answered