7 June 2021 - Regulatory changes introducing a new framework for the regulation of personalised medical devices commenced on 25 February 2021, including a transition period for eligible manufacturers and sponsors until 1 November 2024.

During the implementation phase a number of sectors have raised concerns over the impact of the new framework including comments that the new regulatory requirements are:

• A duplication of existing regulation already provided by professional accrediting bodies or other regulatory bodies;
• The classification of certain requirements for some devices were excessive compared with the actual risk posed by the device
• The regulatory burden associated with compliance is unreasonable.

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