# #357: The State of UDI Across the World

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-03-07
- Length: 52m
- Episode: 357
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-07-357-the-state-of-udi-across-the-world
- Listen: https://podcast.greenlight.guru/episode/357-the-state-of-udi-across-the-world

## Summary

Gary Saner, a UDI expert and co-chair of the industry's structured product labeling technical team, discusses the evolving global landscape of Unique Device Identification (UDI) compliance with host Etienne Nichols. Saner highlights critical upcoming deadlines in the European Union, specifically the potential 2025 mandatory reporting window, and contrasts these with the simpler, US-aligned implementation in Australia. He outlines common pitfalls such as data cleansing, deprecated nomenclature, and the failure to build scalable, global systems, while recommending early engagement with technology solutions like ReedTech to manage complex regulatory requirements.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-07-357-the-state-of-udi-across-the-world#t=0) Introduction: Gary Saner and the Global UDI Landscape
- [4:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-07-357-the-state-of-udi-across-the-world#t=283) European UDI Deadlines: MDR, IVDR, and UDI-MED Reporting
- [14:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-07-357-the-state-of-udi-across-the-world#t=844) Australia's TGA Approach: Alignment with the US Model
- [25:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-07-357-the-state-of-udi-across-the-world#t=1546) Emerging Markets: Saudi Arabia, Switzerland, and Brazil
- [33:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-07-357-the-state-of-udi-across-the-world#t=1985) Common Pitfalls: Data Quality, Cleansing, and Governance
- [39:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-07-357-the-state-of-udi-across-the-world#t=2379) Case Study: Small Company Success with ReedTech
- [42:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-03-07-357-the-state-of-udi-across-the-world#t=2561) Strategic Recommendations for Global Compliance

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- ReedTech (company)
- UDI-MED (other)
- TGA (other)
- GMDN (other)
- HL7 (other)

## Related episodes from other shows

- [216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou) (Let's Combinate)
- [045 - "Combination Products around the Globe" with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-10-045-combination-products-around-the-globe-with-susan-neadle) (Let's Combinate)
- [054 - "EUDAMED" with Richard Houlihan](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan) (Let's Combinate)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [015 - "Would You Use it on a Family Member?" with Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi) (Let's Combinate)

## Citing this page

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