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Reed Tech Submits First M2M UDI Submission to the AusUDID Pre-Production System

Dec 7, 2023 | Medical Devices, Unique Device Identification

In recent news, Reed Tech became the first company to submit a device record (machine-to-machine) to the AusUDID Pre-Production system successfully.

What is the AusUDID Preproduction System:

The AusUDID Preproduction System is a crucial component of the Australian Unique Device Identification (AusUDID) system, designed to enhance the tracking and monitoring of medical devices throughout their lifecycle. The AusUDID Preproduction System serves as a testing ground for the AusUDID system before its full-scale implementation, allowing stakeholders to assess its functionality, identify potential issues, and streamline the integration process.

The AusUDID Preproduction System is a simulated environment that imitates real-world scenarios to test the effectiveness of the AusUDID system. It allows manufacturers, healthcare providers, and regulatory authorities to work together in a controlled environment, ensuring seamless interoperability and compliance with industry standards. Additionally, the AusUDID Preproduction System helps validate unique device identifiers (UDIs), which are crucial in identifying and categorizing medical devices.

How is Reed Tech Participating in the UDI Technical Working Group

Reed Tech participated in the initial testing of the pre-production environment, which had limited access and did not allow for M2M submissions after the initial setup of our AusUDIDI machine-to-machine (M2M) account and test SPL record submission. Reed Tech received draft HL& SPL M2M specifications for review in October 2023. On November 1st, the life sciences product team completed a walkthrough of M2M onboarding and processes with the TGA AusUDID team. Finally, on November 29th, Reed Tech became the first external tester of machine-to-machine submissions for AusUDID.

Here are some important upcoming dates in the AusUDID timeline:

  • 2022-Jul-04 AusUDID Sandpit (open)
  • 2023-Apr-24 AusUDID Pre-Prod (limited, test)
  • 2024-Q2 Vol Labeling/Data (@regs)
  • 2025-Q2 +1 Required Labeling/Data (MD III, IIb)
  • 2026-Q2 +2 Required Labeling/Data (MD IIa)
  • 2027-Q2 +3 Required Labeling/Data (MD Is, IVD 4,3,2)
  • 2028-Q2 +4 Req’d Labeling/Data (IVD 1instr/sfw)

More links and information:

We will continue to monitor Australia TGA progress for UDI and provide updates. Contact Reed Tech to see how product data management can be handled effectively and efficiently through flexible team roles and data validation tools in a dedicated solution such as SingleSource™.

Email us: [email protected]