Unique Device Identification (UDI) in the Medical Device Market

Helping You Understand Global Requirements and Best Practices

What is UDI?

UDI stands for Unique Device Identification, a system that aims to improve the traceability, safety, and post-market surveillance of medical devices worldwide.

Each medical device placed on the market must bear a globally unique identifier, making it easier to:

✅ Identify devices clearly and accurately
✅ Track devices in case of recalls or adverse events
✅ Support post-market surveillance activities
✅ Facilitate supply chain management
✅ Enhance transparency for healthcare professionals and patients

Structure of UDI: DI and PI

UDI is composed of two main elements:

1 Device Identifier (DI)

The fixed part of the UDI
Identifies the specific version or model of the device
Assigned by an Issuing Agency (GS1, HIBCC, ICCBBA, IFA)
Linked to the device’s registration in national/global UDI databases

2 Production Identifier (PI)

The variable part, identifies production information such as:
- Serial number
- Batch/lot number
- Manufacturing date
- Expiration date
- Software version (if applicable)

Example:
UDI = DI + PI = "12345678901234" + "SN98765EXP2025-06"

UDI Issuing Organisations

Currently, these bodies are recognised as official UDI Issuing Agencies worldwide:

Issuing Agency Common Use

GS1 Most widely adopted globally

HIBCC Often used in the US, especially for hospital products

ICCBBA Used for blood, tissue, and cellular therapy products

IFA Used primarily in Europe (especially pharmaceuticals & combo products)

👉 These agencies provide standards and tools to generate UDI codes according to regional regulations.

Where is the UDI placed?

✅ On the device itself (direct marking) → if size and design allow it
✅ On the device packaging (primary & secondary packaging)
✅ In the UDI Database maintained by regulatory authorities

Typical hierarchy:

Package level UDI placement required

Device itself Yes, if direct marking is feasible

Primary packaging (box, pouch) Yes

Secondary packaging (outer box) Yes

Transport packaging No UDI required

UDI should appear in two forms:

1 Human-readable interpretation
2 Machine-readable format (barcode, QR code, DataMatrix)

Global Regulations and Resources

USA (FDA)

21 CFR 801 Subpart B

GUDID

EU MDR (2017/745) Chapter III, Article 27

EUDAMED UDI/Device module

China (NMPA)

NMPA UDI Requirements (CN)

NMPA UDI Database

Australia (TGA)

TGA UDI guidance

Australia UDI Database (being implemented)

Japan (PMDA)

Japan UDI Requirements

Japan UDID

South Korea (MFDS)

MFDS UDI Implementation Guidelines

Korea UDID

Taiwan

TFDA Guidlines

Udid.fda.gov.tw

UDI Deadlines

There is risk-based at international implementation of UDI. The fewer risk medical device has, the later UDI is to register in respective database.

Region Class III Class II Class I

USA 2014 2015 2018

EU 2021 2023 IIa and IIb 2025

China 01/2021-06/2022 01/2024 partly ?

Australia 07/2026 07/2026 IIb, 07/2027 IIa 07/2028

Taiwan 06/2021 implant 06/2023 NA

06/2022 ALL

Conclusion

UDI is a global trend.
Manufacturers must adopt UDI not only to comply with regulatory requirements but also to:

✅ Improve supply chain transparency
✅ Support digital health initiatives
✅ Ensure patient safety

👉 The UDI-DI and attribute are keys to fill at international database.

👉 Contact us to support any international activities of UDI as listing in Chinese, US or EU database (EUDAMED)