Response to Therapeutic Goods Administration Unique Device Identifier (UDI) Consultation Paper 3 October 2022

AHPA responded to the Therapeutic Goods Administration’s Consultation Paper on Unique Device Identifiers Detailed consideration for implementing the proposed Australian medical device UDI regulatory framework (‘Paper 3’) on behalf of Australian Orthotic Prosthetic Association, Australian Podiatry Association, Occupational Therapy Association, Pedorthic Association of Australia, Australian Hand Therapy Association.

The paper was primarily authored by our member the Australian Orthotic Prosthetic Association (AOPA), but represents the views of those member allied health professions that are most impacted by the issue.  In our paper we argued that the UDI regulatory framework should not extend to Class 1 medical devices, particularly for those that are provided under point of care manufacture.

This position is consistent with the US regulatory framework for these types of devices.