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Dear Members, please be advised that TGA Australia are running a consultation on the Conformity Assessment Procedures for medical devices – proposed amendments. The consultation closes 27th Feb 2026. Please provide any feedback to regulatory@bivda.org.uk

This is particularly relevant as TGA Australia is a proposed jurisdiction that will be recognised by the MHRA for international reliance, under the proposed changes to the UK Medical Device Regulations.

TGA Public consultation: Conformity Assessment Procedures for medical devices – Proposed amendments

We want your feedback on the proposed changes to the conformity assessment procedures for medical devices.
Ben Kemp