TGA’s Australian UDI Database: Deadline Update

by Innovit Corporate Affairs | December 7, 2023 | News

Australia’s healthcare landscape is on the brink of a transformative change with the imminent launch of the Australian Unique Device Identification (AusUDID) database by the Therapeutic Goods Administration (TGA). With the AusUDID set to go-live in the second quarter of 2024, all medical device manufactures selling into the Australian market need to be aware of the effective registration deadlines and requirements.

AusUDID Registration Deadlines (as of Dec 2023)

The registration deadlines are broken up by risk class and type. Moderate to high risk (Class III and IIb) medical devices face the first registration deadline starting in 2025, followed by low to moderate risk (Class IIa) in 2026. Starting in 2027 low risk (Class Is) devices and moderate to high publish risk invitro diagnostics (Class 3 and Class 4) are required to be registered, followed by moderate to low risk IVD (Class 2 and Class 1) in 2028.

Deadline Medical Devices Invitro Diagnostics
Q1 2025 Class III and Class IIb  
Q1 2026 Class IIa  
Q1 2027 Class Is Class 4 and Class 3
Q1 2028   Class 2 and Class 1

 

Don’t Delay START Now!

Although the production system is set to go live 2024, testing environments are available now. It is industry best practice to utilize testing environments to ensure data accuracy of regulatory attribution and message flow management of UDI records. Specifically, for the TGA, although based closely on the HL7 standard implemented by the FDA’s GUDID, you will find there are distinct TGA system specific attribution that will be required from manufacturers and a relationship authorization with Australian device sponsors that will need to be managed.

Want to start testing with Innovit? Speak to our Master Data Experts

STEPS to get ready to connect to AusUDID

With over 24 years of experience in product information and master data management Innovit has learned a lot on how to best prepare organizations to connect to commercial and UDI registries. Below are 4 steps every manufacturer should take in preparation to connect to registries like the AusUDID.

  1. Understand the Requirements: Although attribution may seem similar across registries, often times they can greatly differ in definition and structure. Manufactures need to be comfortable with the regulatory definitions of the information being requested and knowledgeable about the technical specifications required for entry. In addition actor identifiers and sponsor to representative authorization is very local and tend to differ greatly by regulatory jurisdiction.
  1. Review Source Systems: Once the attribution is understood, manufactures should review where the associated attribution resides within there source systems, and if any conversion or transformation logic needs to be applied or new attribute fields need to be created. UDI centric Product Information Management systems enable the aggregation of source system information into structure process of product content maintenance and submission of product records.
  1. Develop A Connectivity Plan: Align internally with stakeholders to review your global UDI registration process and how it may need to be adapted to compliantly connect to a new registry. Larger manufactures with legacy systems that were designed to be regional in nature, often realize the need to centralize UDI product information, within a given team or task routed process. Look at some uses cases where Innovit has help medical device manufacturers.
  1. Test, Test, Test!: Mistakes can be costly! Mistakes are greatly mitigated when manufactures have structured and well understood processes to manage and control the flow of regulatory and commercial data. Testing and preparedness ensures your organization doesn’t fall behind registry deadlines that force you to deviate from your standard processes to rush the registration of product information into databases.

 

 

Photo by Steven Wei on Unsplash
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