UDI consultation paper 3: Detailed considerations for implementing the proposed Australian medical device UDI Regulatory Framework

The TGA thanks respondents who provided submissions in response to the public consultation paper Detailed considerations for implementing the proposed Australian medical device UDI regulatory framework which closed on 11 October 2022.

84 submissions were received, with most representing medical device sponsors or manufacturers. Other respondents included industry peak bodies, health professionals, a clinical quality registry, a state health organisation, and other international governments. No submissions were received from General Practitioners, export-only Australian manufacturers, or consumers.

Responses demonstrated overall support for the regulatory intent proposed in the consultation paper. Submissions showed strong consensus across all stakeholder groups, for Australia to globally align its UDI system by accepting UDI-compliant labelling from the EU and US and using internationally recognised Issuing Agencies.

Responses supported the UDI intentions expressed in the consultation paper including:

• Australia accepting devices with EU and US compliant labelling
• UDI assignment using the Issuing Agencies approved in the USA and EU and not creating a formal framework for authorising Issuing Agencies
• the Australian Register of Therapeutic Goods (ARTG) ID being provided for every UDI
• the UDI data being kept up to date while the device is in commercial supply
• the UDI requirements forming part of the Essential Principles with corresponding sanctions for non-compliance
• providing sponsors with the ability to request a consent to import or supply a medical device that does not comply with one or more of the Essential Principles

Some challenges were identified by some respondents with the acceptance of EU and US compliant labelling. This related to possible confusion and low adoption by healthcare professionals and providers due to additional barcodes on devices and device packaging, and the cost to suppliers and healthcare providers for implementing scanning and software systems to cater for both the EU and US labels.

Respondents supported UDI being mandatory for Class II devices and Class 2 IVDs and were mixed in relation to whether UDI should be required for Class I medical devices and Class 1 IVDs. Just under a third proposed no UDI requirements for Class I devices, a third supported mandatory inclusion for Class I devices and just over a third supported voluntary provision of UDI for the Class I devices and Class 1 IVDs. Many respondents considered that Class I Measuring and Class I Sterile devices may require UDIs.

There was little support for the UDI requirements to apply to:

• medical devices in the emergency stockpile
• medical devices that are exempt from inclusion in the ARTG
• replacement parts where the original part was in scope.

All respondents supported Australia’s approach for progressive implementation of UDI by device class and confirmed this was consistent with International Medical Device Regulators Forum (IMDRF) guidance and the approaches of other countries. Many asked for:

• the implementation dates to align with the EU dates, or for Australia to not implement before the EU
• the UDI requirements being delayed for any contentious devices (e.g. surgical loan kits, and devices not included in the ARTG) with all seeking the compliance dates for these device types to be in the final implementation stages.

All respondents agreed that while the manufacturer was responsible for their medical devices, the associated labelling and UDI data, in Australia the sponsor is ultimately responsible for the UDI data and its provision to the Australian UDI database. Respondents asked for flexibility in the provision of data to the database and the ability for the sponsor, the manufacturer, or a regulatory agent or third-party to submit data to the Australian UDI database.

All respondents supported the Australian UDI database permitting changes to the UDI data, including the ability to correct the UDI data. This would allow data providers to maintain the integrity of the data without introducing significant additional administrative overheads.

A range of feedback was received on the proposed UDI data elements with consistent recommendations to remove some data elements and refine data validation rules. The AusUDID data dictionary will be updated to reflect this feedback.

No respondent supported the proposal for Australia to introduce methods for capturing a reason for a device identifier (UDI-DI) change. Every respondent supported the need to communicate changes in a UDI to medical device end users and asked the TGA to implement a method that is internationally consistent. This will require extensive international consultation and agreement.

A high proportion of respondents argued that no other international UDI systems charge fees for their UDI database. However, they also acknowledged with the TGA operating under a full cost-recovery model, if recovery of the UDI costs was to occur, the preferred position was via an increase to the annual ARTG charge over additional fees. This was considered the most simple and predictable, with minimal invoicing.

We have analysed all responses and undertaken some further targeted discussion on matters raised. All feedback will be provided by the TGA to the Minister and be used to inform any future policy and regulatory decisions by the Australian Government. The TGA will continue to work closely with stakeholders as we progress the implementation and we appreciate the feedback and thank all respondents.

Only answers from respondents who gave permission are published. However, all responses are included in the analysis of this consultation.