Exploring options for the introduction of an Australian Unique Device Identification (UDI) System: UDI consultation paper 2

Feedback updated 19 May 2021

Results updated 19 May 2021

The TGA thanks respondents who submitted a response to the public consultation paper, Exploring options for the introduction of an Australian Unique Device Identification (UDI) System: consultation paper 2, which closed on 24 December 2020.

Ninety responses were received with sixty percent of submissions from medical device manufacturers and/or sponsors. The remaining respondents represent most other sections of Australia’s health system. However, it was noted that no submissions were received from Registries or General Practitioners.

Overall, responses continued to demonstrate strong support for the implementation of an Australian UDI Database and its role in enabling benefits across the broader healthcare system including for patients, hospitals, healthcare practitioners, governments and regulators.

Some smaller Australian manufacturers of low-risk Class I (non-sterile, non-measuring) devices, while supporting an Australian UDI, were concerned with the impact and increased burden and cost to their businesses.

Respondents expressed strong support for both the manufacturer and the sponsor having a role in providing the data for an Australian UDI, with most respondents seeking the capability for bulk upload and download of data via an electronic interface offered by the TGA. Many asked for the TGA’s data exchange method to be similar to the U.S. FDA system, which gives manufacturers / sponsors the ability to enter data into a “sandpit” environment where they update and confirm the UDI data before it is officially recorded against a medical device.

A period of twelve months is the preferred lead-time between the publishing of the regulations and when the UDI becomes mandatory – this was considered the minimum period necessary for organisations to prepare their people, business processes and ICT solutions.

Respondents had strong views both for and against Australia’s adoption of the European Union (EU) Basic UDI Device Identifier (Basic UDI-DI). Almost half considered Basic UDI-DI could provide another means for device grouping and create different UDI associations with product recalls, adverse events or other post market analysis. Others argued it would not provide additional benefit as the Australian Register of Therapeutic Goods (ARTG) identifier serves a similar purpose and the EU system is not yet operational nor globally harmonised.

There was specific feedback on the compliance impact to manufacturers and sponsors that supply to multiple markets, all of which are implementing a UDI framework. Respondents were equally divided on whether Australia should align with the U.S. FDA or the EU.

Almost half of the respondents raised concerns with a phased implementation, arguing that a Limited First Phase would extend the overall implementation timeframe, increase the cost and risk of managing devices between jurisdictions and take longer to realise benefits.

To address this, respondents suggested extending the Limited First Phase to include all U.S. manufactured and Australian supplied devices that are present in the U.S. FDA’s Global Unique Device Identification Database (GUDID). They suggested this approach could help Australia introduce UDI faster and limit the impact on many U.S. manufacturers because their systems and processes would already cater for a UDI.

Proponents of this accelerated approach acknowledged that harmonising Australia’s system with the U.S. FDA and EU was the long-term goal. They suggested that the TGA could commence its initial activities using U.S. FDA data and rules (as it is operational) with the EU rules folded in when they are operational.

A high proportion of respondents expressed a strong interest in continuing to participate in the TGA’s ongoing design and implementation activities, either as members of a Working Group or through ongoing communication and support activities.

We have analysed all responses and the results will inform Australian Government policy and regulatory drafting decisions. The TGA will continue to work closely with stakeholders as we progress the implementation and we appreciate the feedback and thank all respondents.

Published responses

View submitted responses where consent has been given to publish the response.