Medical Devices supplied into Australia under the Therapeutic Goods Administration's regulatory framework.
Unique Device Identification (UDI) Consultation 3 - Detailed considerations for implementing the proposed Australian medical device UDI regulatory framework; (76 page(s), in English)
The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health and Aged Care, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government's reforms, including the introduction of a unique device identification (UDI) system for medical devices supplied in Australia.
Changes to the Therapeutic Goods Act 1989 were passed by the Australian parliament in February 2021, to allow for the establishment of the UDI database and the introduction of related requirements. For the system to be operational, there is a need to provide for the establishment of the UDI database and for setting out of related requirements, in the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations).
This consultation relates to the details of the proposed regulatory framework, including seeking feedback on:
· the impact of accepting both European and USA compliant labels
· acceleration of delivered benefits through a phased implementation approach
· scope and exemptions in applying the UDI
· providing and maintaining data over the full life of the device
· UDI related fees and charges
· UDI labelling and supporting documentation
· any potential regulatory burden
· adoption and use in the broader healthcare setting