Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation

Closes 13 Nov 2024

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Proposal 16: Transitional arrangements

Proposal 16(a). Do you agree with the proposal to apply a 4-year transition period for existing or new inclusion applications when the proposed amendment takes effect?
Proposal 16(b). Do you agree with the proposal to apply a 6-year transition period for any current ARTG entries when the proposed amendment takes effect?
Proposal 16(c). Provide reasons for your position (optional)