Australian UDI implementation timeline and impact on overseas manufacturers

Author: Jenny Lin, Senior Manager, Medical Device/IVD, Cencora PharmaLex Australia

With the Australian Unique Device Identification (UDI) regulations set to come into force in mid-2024[i], overseas manufacturers and their Australian sponsors should be aware of the compliance timeframe and the relevant labeling requirements in Australia. This will help to minimize the potential impact on their existing labeling system for their medical devices and in-vitro diagnostics (IVDs).

The TGA plans to enforce compliance at minimum of a 12-month period after the UDI regulations take effect[ii]. The mandatory compliance dates at the end of the transition period come with a staggered schedule, according to the device class and the date of manufacture. The sponsors and their manufacturers can voluntarily comply with the UDI requirements after the “compliance date”- this includes UDI labeling and UDI data provision (i.e., AusUDID registration); however, they must comply with the requirements after the end of transition period. Table 1 provides an example of the mandatory UDI compliance deadlines based on the presumed/estimated compliance dates. Note that existing devices which require relabeling or remanufactured after the original supply date must comply with the UDI requirements at that time2.

Table 1 Australian UDI Implementation Timelines (illustrative only)2*

*This table is for illustrative only and is drafted based on the information obtained by the TGA at the time of writing this article. The end of transition periods will be subject to the actual compliance dates and the relevant transition duration for each risk class as announced/updated by the regulator. This table also excludes timelines for direct marking- the compliance date for direct marking may be different from those for UDI labeling and UDI data provision. The author and PharmaLex encourage readers to review the information and make their own determinations rather than rely on the accuracy of the information included in this table.

How the TGA timelines will impact on the global UDI implementation

TGA will accept labels that are compliant with the US or EU UDI regulations if the UDI   is issued by a TGA recognized issuing agency. Since UDI compliance is already mandatory for all device classes in the US, impact on devices that are already supplied in the US is minimal. For devices supplied only in the EU, sponsors need to be aware of potential out-of-step implementation timeline between AU and EU[iii]. Table 2 outlines the current implementation timelines in the EU:

Table 2 European UDI Implementation Timelines

Whist the timelines for mandatory UDI labeling (and potentially direct marking) in Europe might be earlier than Australia, the deadlines to submit UDI data to the UDI database could be earlier in Australia due to the delay of the EUDAMED full implementation3.

In addition, overseas manufacturers need to consider incorporating the AU UDI requirements into their Essential Principles Checklist[iv] and the quality management system (QMS) processes, including, for example, processes to assign, register and update UDI data in the AusUDID.

 [i] About UDI in Australia, TGA. https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub/about-udi-australia#:~:text=We%20have%20developed%20the%20AusUDID,visit%20UDI%3A%20News%20and%20updates.

[ii]  Australian UDI requirements for sponsors and manufacturers, TGA. https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/australian-udi-requirements-sponsors-and-manufacturers

[iii] EUDAMED Overview, European Commission. https://health.ec.europa.eu/medical-devices-eudamed/overview_en

[iv] Essential Principles checklist, TGA, Feb 2024. https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist