14 de agosto de 2019

TGA NEWS: Feedback on the Proposal to introduce a UDI System for Medical Devices in Australia

From: www.tga.gov.au

It is available on the TGA website, the Agency's summary about the submissions received in response to the public consultation "Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia", closed on last 18th February. 
Read below.

TGA summary

The consultation sought feedback on the proposal to introduce a UDI System in Australia, with the requirements aligned with the International Medical Device Regulators Forum (IMDRF) UDI Application Guide. The consultation also sought feedback on options for establishment of the Australian UDI database (AusUDID); the scope of devices to which UDI requirements should apply; the core data elements; and linkages between the Australian Register of Therapeutic Goods (ARTG) and AusUDID as well as broader data linkages with other data systems.

Submissions received in response to the consultation showed a strong consensus across all stakeholder groups for the need to introduce the UDI system in Australia. The majority of respondents also considered that the TGA should be responsible for establishing and managing the AusUDID, and that it should be linked to the ARTG as well as other databases.

Most submissions also supported the use of the IMDRF guidance as the basis for establishing the system, with several respondents also suggesting that there should be consistency with other international jurisdictions.

Stakeholders also provided feedback on a number of other issues raised in the consultation, including:
  • The Australian UDI requirements, including UDI labelling requirements, should be aligned with the IMDRF guidance, and be consistent with major jurisdictions.
  • Australia should accredit internationally recognised Issuing Agencies (organisations that issue unique device identifiers for individual products).
  • There is the need for clarity on who is responsible for submitting the UDI data into the AusUDID, especially where more than one sponsor holds pre-market authorisation for the same device.
  • Some respondents proposed the exemption of low-risk devices (Class I non-sterile with no measuring function) from the UDI requirements suggesting that there is minimal safety benefit (but some regulatory burden) in including them in this system. A few other responses suggested excluding other categories of devices (e.g. devices sold through retail outlets, custom-made devices, or investigational devices).
There was strong support for a staged implementation of the UDI system and alignment with the European timeframes. Several submissions also considered that proposed transition time frames should take into account the time required to develop and implement an Australian UDI database.

Some respondents raised concerns about possible cost and resource impacts on industry associated with populating and maintaining the AusUDID, especially cost implications for some manufacturers and sponsors supplying low cost/low margin products. However some respondents saw positive impacts and broad savings in terms of improved ability of health systems to store and access information about individual devices, simplified device tracking and communication, the ability to link device information to individual patients through registers, and the improvement in access to information about post-market issues.

This feedback has informed work to develop proposed legislative amendments to support the introduction of a UDI system in Australia.

All submissions that gave permission to be published on the TGA website are available to download in PDF format here.