Author: Jenny Lin, Senior Manager, Medical Devices/IVD, PharmaLex Australia
Progress toward finalizing Australia’s Unique Device Identification regulations has been delayed, resulting in deferment of the voluntary compliance date.
Nevertheless, the Therapeutic Goods Administration (TGA) has been making steady progress and so far has completed several key steps in preparation for the implementation of UDI in Australia.
Over the past several years, the TGA has published three consultation papers aimed at informing the planning, design and proposed intent of the implementationi. The agency has also held multiple webinars over the past two years, covering various UDI-related topics including introductory sessions for those new to UDI, the benefits of UDI across the supply chain and learnings from UDI implementations in other markets1.
The TGA also held an early pilot version of the Australian Unique Device Identification Database (AusUDID) “Sandpit” over the six months from June 2022 to January 2023ii. The purpose was to enable user to share their feedback on the usability and design of the database. Most recently, the agency has launched the AusUDID Pre-Production version and has invited a few sponsors and manufacturers to conduct early testingiii.
What is UDI?
UDI is a combination of numbers, symbols and letters given to each model or version of a device to support unambiguous identification of the device. The objective of UDI is to enable global tracking and tracing of medical devices and in vitro diagnostic (IVD) devices throughout the supply chain all the way to the patient record. This oversight helps to enhance supply chain management, clinical workflow, patient safety, and post market regulatory activities such as adverse event reporting and recalls.
A UDI is composed of two parts:
- Device Identifier (UDI-DI) – this is a fixed and static part that identifies the manufacturer and the specific model or version of the device
- Production Identifier (UDI-PI) – this is a dynamic part that includes production information such as lot, batch or serial number, manufacture data and expiration date.
Some devices may not have or only have a partial UDI-PI (for example, including expiration date but not a lot number), but every device will have a UDI-DI.
TGA currently recognizes UDIs issued by the following three Issuing Agencies:
- GS1, a voluntary UDI issuing agency based on many global regulations aimed at enabling manufacturers to use these GS1 standards to implement UDI in multiple marketsiv.
- Health Industry Business Communications Council (HIBCC), a standards development organization that seeks to support information exchange between healthcare trading partnersv.
- International Council for Commonality in Blood Banking Automation (ICCBBA), which is another standards organization that developed and manages the ISBT (International Society of Blood Transfusion) 128 Standardvi.
Which devices will need a UDI in Australia?
While yet to be finalized, the current proposal requires all IVDs and all medical devices to comply with the UDI regulations except for the following exempt devicesvii:
- Class I medical devices and Class I medical devices with a measuring function (Class Im)
- Class 4 in-house IVDs
- Class 1 IVDs that are not:
- Instrumental/analyser IVDs (GMDN collective Term 943)
- Software IVDs (GMDN Collective Term 944)
- Devices that are exempt from the Australian Register of Therapeutic Goods (ARTG) under Schedule 4 of the Therapeutic Goods Regulations 1990, including:
- Export only
- Custom-made devices
- Patient matched with a volume of five or fewer imported, exported or supplied per financial year
- Exempt under Special Access Scheme (SAS) or Authorised Prescriber Scheme (APS)
- Class 1, 2 and 3 in-house IVDs
UDI requirements for systems or procedure packs (SOPP) and surgical loan kits have also not been finalized; however, early indications from the TGA suggest it is likely both will require a UDI for the “set” as well as for the individual components which are classified as Class Is, IIa, IIb or Class III devices. Individual components do not require UDIs if they are not commercially available on their own, generally known to and understood by the user (typically healthcare professionals) and cannot be removed from the pack/system, or otherwise exempt from UDI requirements.
Where should UDI be provided?
The UDI must be provided on the device labels. In general, a device label that is compliant with the EU and US UDI regulations are acceptable in Australia; however, the label must also be compliant with the Australian’s medical device regulations (such as Essential Principles Clause 13.3, which lists all information that must be provided with a medical device). While it will be mandatory for some materials provided with the device to bear a UDI, for some this will be optional. The TGA current proposals are6:
- Direct marking on the device – mandatory for all devices except for
- Implantable devices
- Reprocessed devices between uses on the same patient
- When direct marking would interfere with the safety or performance or effectiveness of the device
- When it is not technologically feasible to directly mark the device
- UDI is mandatory for packaging labels, and each packaging level containing a fixed quantity of devices must have a UDI. For example, a primary (base) package containing a single device, a carton (second package) containing 20 base packages, and a case (tertiary packages) containing 4 cartons – all of which should bear its individual and unique UDI-DI.
- Instructions for Use – optional
- Patient Information Leaflets – optional
- Patient Implant Cards – mandatory
- The full UDI (UDI-PI and UDI-DI) must be machine-readable
- UDI-DI must also be human-readable.
In all of the above, the mandatory implementation timelines will depend on risk classification.
In addition, UDI will be required when reporting to the TGA for at least the following post-market activities:
- Mandatory and voluntary recalls
- Adverse event reports
The Australian UDI database (AusUDID)
The Australian UDI Database (AusUDID) is currently in the “pre-production” phase for participating sponsors and manufacturers to test the database submission functionalities. Aside from the UDI-DI, there is other essential information required to be uploaded to the database, including the following 6 areas:
- Device Identifiers, such as primary DI and issuing agency
- Device Information, such as model name, device class, Global Medical Device Nomenclature (GMDN), device description
- Packaging Data, such as packaging type and DI, quantity per package
- Production Data, such as whether the lot/batch number is provided on the label
- Sponsor and manufacturer details, such as Australian Register of Therapeutic Goods (ARTG) ID, Sponsor ID, and Manufacturer ID
- Clinical characteristics, such as clinical size, storage and handling conditions, critical warnings, and number of uses
Not all fields are mandatory, and a submitter may select different submission methods depending on number of entries, in other words, whether the information is uploaded per UDI-DI or submitted in bulk, either via Microsoft Excel files, Machine-to-Machine (M2M) or National Product Catalogue (NPC) if there are a large number of multiple entries.
UDI Implementation Timelines
Whilst not being finalized, TGA is expected to introduce the UDI compliance in a phased approach based on the device risk classification. It is estimated that the implementation of the UDI regulations and the launch of the AusUDID official version will take place in 2024, with stage zero being voluntary compliance for all device risks, followed by mandatory compliance for (1) Class III/IIb, (2) IIa, (3) Is and Class 4,3, 2 IVDs to (4) Class 1 IVDs. The time between each stage is estimated to be 12 months.
Quality manufacturing system
TGA will inspect compliance with the UDI requirements as part of audit processes once the UDI regulation comes into force. Manufacturers need to establish and maintain the UDI process as part of their quality management systems. This includes UDI assignment, data maintenance, change management, consistency across the registered data with the AusUDID, product labels, direct marking on devices (where applicable), and other applicable documents such as Patient Implant Card.
What to expect?
Australian sponsors should start to plan and take actions now to be prepared.
Key steps should be to establish and maintain UDI relevant procedures that comply with the Australian UDI regulations within the QMS. Sponsors should also allocate a UDI that has been sourced from one of the three Australian approved Issuing Agencies noted above.
It is important to include the UDI on the device label, packaging and, if feasible, directly marked onto the device. Be ready to submit UDI and related information to the AusUDID once the database is live. And, finally, ensure UDI is included in all regulatory activities such as recalls and adverse event reporting.
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