Achieve Global UDI
Compliance

Manage and Submit validated UDI Data to several
Authorities Worldwide.

Visu UDI centralizes Master Data Management (MDM) ensuring
your medical device data is accurate, compliant, and ready for
submission to the FDA GUDID, EUDAMED, NMPA, and others.

“Managing UDI requirements individually country-by-country is both
cumbersome and expensive.”

Request a Demo

Evolving Global UDI Regulations

As health authorities from the US, EU, China, South Korea, and Australia enforce stricter tracking standards, medical device manufacturers face a key challenge: data fragmentation.

Managing several spreadsheets, legacy systems, and constantly changing XML standards increases manual work and also the risk of non-compliance.

A Strategic Data Foundation

You need more than just a publishing & submission tool; you need a strategic data foundation that lets you add/update once and rest should be managed by system (from validation to verification to country specific XML/XLS and lifecycle updates).

Visu UDI does exactly that.

Choose from 3 modals that fit your business requirements and budgets

Few Products and you just need XML/XLS conversion:

Maintain your data in Excel files
Simple Portal access provided to you for upload, validate and convert to XML or XLS
Pay-per-use model

If you do not have master data and other tools currently

Master data management functionality is included to maintain your system-of-truth
Data can be updated by each business function : Product, Regulatory, Packaging, Labeling, UDI and others. User friendly individual screens provided for functional data management
Visu UDI checks validations
Our proprietary smartRules engine picks up daily data changes and if they qualify for any country specific UDI submissions, then it’ll publish country specific UDI files
For any validation failures, you’ll receive alerts for you to manually correct data
Lifecycle maintenance of data is performed in Visu UDI. No excels needed
Cloud based and fully validated solution
Annual License model

If you have PLM/ERP and other systems

Visu UDI comes with several interfaces to push/pull data from your data sources
Data changes in your source systems are pulled once
All data validations are performed to alert any data issues
Option : If you do not have RIM, you can maintain country specific Regulatory/License details, packaging, Labeling, UDI details in Visu. User friendly individual screens provided for functional data management
Our proprietary smartRules engine picks up daily data changes and if they qualify for any country specific UDI submissions, Visu UDI will publish country specific UDI files
For any validation failures, you’ll receive alerts for you to manually correct data (in this system or your PLM/ERP)
M2M Submissions gateway included for auto-submissions and acknowledgement management
Cloud based or On-Prem options

Other Salient Features

1. Compliance you can count on

Multi-Market Coverage: Ready-to-use templates for FDA (USA), EUDAMED (EU), NMPA (China), TGA (Australia), and more
Regulatory Intelligence: System rules are updated automatically as global regulations evolve, ensuring you never miss a compliance shift.

2. Seamless EUDAMED Submission & Global Gateways

Tackle the complexities of the European Union’s Medical Device Regulation (MDR) and IVDR with confidence.

Direct M2M Connectivity: Automate EUDAMED Submission via machine-to-machine connections, eliminating manual file handling.
Global Gateways: Pre-configured connectors for FDA GUDID (HL7 SPL), China NMPA, and other health authority databases.
Ack & Nack Management: Real-time tracking of submission status with automated handling of acknowledgments and error reports.

3. Advanced Regulatory Data Validation

Prevent costly rejections before they happen. Our validation engine validates your data against the strict business rules of each health authority before submission.

Pre-Submission Logic: Detect missing attributes, format errors, and inconsistency issues instantly.
Audit Trails: Maintain a complete history of data changes, user actions, and validation results for total traceability.

4. Integrated Master Data Management (MDM) / RIM

Break down silos between your regulatory affairs, supply chain, and quality teams. DDi integrates UDI data directly into your broader Master Data Management (MDM) / RIM ecosystem.

SmartMaster Component: Pool data from disparate sources into a unified, clean master record.
Product-Level Linking: Link UDI data with registration certificates, dossiers, and labeling records for a holistic view of product health.

5. Flexible UDI Integration

Your data lives everywhere—ERP, PLM, and Labeling systems. Visu UDI connects them all.

System Agnostic: Robust APIs and connectors allow for seamless UDI Integration with SAP, Oracle, Agile PLM, and major labeling software.
Data Syndication: Automatically push validated UDI data to GDSN data pools and commercial partners without manual intervention.

The DDi Advantage: Visu UDI

Global compliance day one and ongoing
Ready out-of-box solution with multiple options
Proven technology fully validated and secure

Over a decade of experience
Quick onboarding and global support for ongoing needs

Future-Proof Your UDI Strategy Today

Don’t let data errors stall your product launch. Join leading life sciences companies using DDi for Global UDI Compliance.

Schedule Personalized Demo

Related Tools

Global Specific UDI Requirements by Countries

2022 Jun – AUSUDID sandpit (beta) — general use, testing
2023 Jan – Regulations and Guidance — in effect
2023 Jan – Voluntary Compliance (high risk Class II, III, AIMD)
2024 – Mandatory Compliance (implants) — UDI labeling, UDI data(Implementation timeframes and compliance dates will be published as soon as they are confirmed)
Approach: similar to EU regulation; UDI/Device registration and UDI labels implemented by MD and IVD classes
UDI Data: ‘EU-like’ attributes reported to AusUDID
Data Sub: Bulk upload via Microsoft Excel files, Machine-to-Machine (M2M) upload via HL7 SPL files and Data transmission via the National Product Catalogue (NPC)
UDI Label: HRI & AIDC; Direct Mark
STD: GS1/HIBCC/ICCBBA, EMDN/GMDN?
Info: Medical Device & IVD

2020 Jun – UDI Barcode inserts required in a few implant product packages; UDI data reported to RNI by healthcare provider
2021 Feb – UDI System Publication
10 July 2025-Class IV (highest-risk) devices
10 January 2026-Class III (high-risk) devices
10 January 2027-Class II (Moderate-risk) devices
10 January 2028-Class I (Low-risk) devices
Approach: Pilot started with package UDI barcodes on Coronary Artery Stents and Hip & Knee Arthroplasty Implants
UDI Data: Few attributes reported by healthcare provider to National Implant Registry (RNI)
UDI Label: DI, Expiry Date, Lot/SN in AIDC (1D or 2D barcode) on (3) Mfr-supplied “Traceability Labels” with product pkg
STD: GS1/HIBCC,ICCBBA
Info: ANVISA (National Health Surveillance Agency)

2022 – Proposal Health Canada UDI
Approach: Ongoing UDI preparation, expected to follow IMDRF UDI recommendations

2019 2H – UDI Pilot, Rules, UDID database tests
2019 Sept 17 – Batch 1 Notice timing and list
2020 Sept 30 – Batch 1 Delay and 69 (64+5) categories
2021 Jan 01 – Batch 1 UDI Data & Label Required
2022 Jun 01 – Batch 2 (Remaining Class III)
2024 Jun 01 Class II
2026 – Class I and Remaining Devices
Website upload or Batch import
GS1, ZIIOT and AHM.

2020 Dec 01 — Actor Voluntary Economic Operator Registration
Currently EUDAMED is voluntary, and its mandatory use date has been postponed multiple times.
Placing UDI-carriers on the labels of Medical devices
- 26 May 2021 – Implantable and class III devices
- 26 May 2023 — Class IIa and class IIb devices
- 26 May 2025 — Class I devices
Direct marking of the reusable devices
- 26 May 2023 — Implantable and class III devices
- 26 May 2025 — Class IIa and class IIb devices
- 26 May 2027 — Class I devices
Placing UDI-carriers on the labels of IVDs
- 26 May 2023 — Class D IVDs
- 26 May 2025 — Class C and B IVDs
- 26 May 2027 — Class A IVDs
Extended transition for legacy devices
- 31 Dec 2027 — class III and class IIb implantable devices (except certain devices for which the MDR provides exemptions)
- 31 Dec 2028 — Other class IIb devices and class IIa, class Im and class Is devices.
UDI Data: 109 attributes to EUDAMED; New BUDI-DI group concept
Data Sub: Website entry/upload or electronic XML (via Data Exchange) to EUDAMED
UDI Label: HRI & AIDC by class (III-2021, IIa/b-2023, I-2025); Direct Mark by class (Label + 2yr)
STD: GS1/HIBCC/ICCBBA/IFA; SRN; EMDN
Info: EC Reg, UDI (European Commission)

Ordinance No 128 of 2022-Guideline for Labeling of Codes on Containers to Identify Medical Devices, In Vitro Diagnostics, etc.
04 Dec 2019 – PMD Act required barcode labels and registration
Dec 2022 – Medical devices (except contact lenses), in vitro diagnostics, and consumable materials other than medical devices require barcode labelling based on international standards for immediate containers/wrappings/retail packaging of medical devices.
Approach: Report device info to database and apply barcode to labels for medical devices and IVDs; future UDI reporting to UDI database
UDI Data: Device reistration includes: Product Code (DI), Expiry Data, Lot #, Serial #
UDI Label: HRI and AIDC (1D GTIN-128 barcode symbol or 2D); no Direct Marking now
STD: GS1
Info: PMDA (Pharmaceuticals and Medical Devices Agency)

2019 Apr 08 – UDI Draft Requirements released
2019/2020 – UDI Pilot
2020 Sep 06 – UDI Formal Requirements (v.3) released
2023 Sep 01 – Class B, C, D devices (was 2022 Sept)
2024 Sep 01 – Class A
Database: SAUDI — DI (Ramz)
Sub: Website upload or Bulk Upload (TBD)
STD: GS1/HIBCC/ICCBBA

1 Nov 2022 High-risk implantables (3) All Coronary stents, orthopedic joint replacement implants, and intraocular lens
1 Nov 2024 Class D (High-risk) General medical devices and IVDs
1 Nov 2026 Class C (Medium-risk) General medical devices and IVDs
1 Nov 2028 Class B (remaining) General medical devices and IVDs
Voluntary Class A (low-risk)
Database: Singapore Medical Device Register (SMDR) for class B or higher medical devices and the Class A medical device database for Class A medical device. For all risk classes through MEDICS
Data Sub: Website XLS upload
UDI Label: HRI & AIDC; Direct Mark
STD: GS1, HIBBC, ICCBBA

2018/2020 – Guidelines for Barcodes & UDI Codes
2019 Jul 01 – Class IV Devices UDI Labeling req’d
2019 Oct – Class IV Devices UDI Labeling req’d
2020 Jul 01 – Class III Devices
2021 Jul 01 – Class II Devices
2022 Jul 01 – Class I Devices
+1 year – Monthly Supply Report Req’d
Approach: UDI data reporting and UDI Label by class AND submit Supply Report (Track & Trace) of ~10 distribution metrics each month
UDI Data: 40 data attributes to IMDIS (Integrated Medical Device Information System)
Data Sub: website XLS upload /complete data / upload file or machine-to-machine XML transfer via API by Local Rep
UDI Label: HRI & AIDC, Direct Mark
STD: GS1/HIBCC/ICCBBA
Info: MFDS, IMDIS UDI System

Events:
- 2015 -Oct: Administrative Guidance
- 2020 – Nov: UDI Announcement
Compliance Timing
- Class III implantables: 1 June 2021
- Class III non-implantables: 1 June 2022
- Class II devices: 1 June 2023
Description
Approach:new device UDI data labels; similar to FDA model
Database: Taiwan UDID (TUDID)
Data: 24 Attributes; similar to FDA (No BUDI)
Sub: Website upload (Web input) or batch upload
Label: HRI & AIDC (1D or 2D), Direct Mark
STD: GS1, HIBBC, ICCBBA
Info: FDA Medical Devices

2021 Jan 01 – Brexit effective, Guidance released
2021 Jan 01 – UK-mfg Class I, Custom, IVD register
2021 May 01 – III, II Implantable, Active Implantable, IVD A register
2021 Sep 01 – IIB other, IIa, IVD B, IVD Self-test register
2022 Jan 01 – OUK-mfg Class I, Custom, IVD register
2023 Jul 01 – CE replaced by UKCA mark; Legislation expected to require UDI
Approach: UK regulatory framework revamped due to Brexit; Mfrs and Devices must be registered in MHRA; GB will NOT comply with EU MDR/IVDR (Northern Ireland will); UDI voluntary field – future UDI legislation will require UDI
UDI Data: ~70 attributes similar to EU reported to DORS (Device Online Reg. System) includes BUDI-DI
Data Sub: Website manual entry or XLS upload (1,000 max records); perhaps future machine-to-machine
STD: GS1/HIBCC/ICCBBA/IFA; GMDN, UKCA
Info: MHRA Medical Devices (Medicines and Healthcare Products Regulatory Agency)

2014 Sep – Class III Devices
- Required to bear UDI on the Device
- Contain Standard date format
- Provide UDI on stand-alone software device
- UDI must be submitted to the GUDID database
2016 Sep – Class III Devices
- UDI as a permanent marking on the device that are intended to be used more than once and reprocessed before each use
- The FDA does not intend to enforce UDI direct mark requirements for Non-Sterile Class III devices that are manufactured and labeled prior to September 24, 2016, when the device’s UDI can be derived from other information directly marked on the device
2016 Sep – Class II Devices
- Required to bear UDI on the Device
- Contain Standard date format
- Provide UDI on stand-alone software device
- UDI must be submitted to the GUDID database
2018 – Sep – Class II Devices
- UDI as a permanent marking on the device that are intended to be used more than once and reprocessed before each use.
- The FDA does not intend to enforce UDI direct mark requirements for Non-Sterile Class II devices, other than LS/LS devices that are manufactured and labeled prior to September 24, 2018, when the device’s UDI can be derived from other information directly marked on the device
2022 Sep – Class I and unclassified devices, other than I/LS/LS devices
- Required to bear a UDI
- Contain Standard date format
- Provide UDI on stand-alone software device
- UDI as a permanent marking on the device that are intended to be used more than once and reprocessed before each use.
- Directly marked with a UDI
- The FDA does not intend to enforce UDI direct mark requirements for Non-Sterile Class I devices and unclassified devices, including Class I and unclassified device constituents of a co-packaged combination product or kit other than LS/LS devices that are manufactured and labeled prior to September 24, 2022, when the device’s UDI can be derived from other information directly marked on the device
2022 Dec – Class I and unclassified devices, other than I/LS/LS devices
- UDI must be submitted to the GUDID database.
Class I CGMP-exempt devices are excepted from UDI requirements.
Approach: Report UDI Data & apply UDI to Labels by class
UDI Data: 57 attributes to GUDID
Data Sub: Website entry or electronic HL7 SPL (via ESG)
UDI Label: HRI & AIDC; Direct Mark
STD: GS1/HIBCC/ICCBBA; DUNS; GMDN/FDA

Achieve Global UDI
Compliance

Evolving Global UDI Regulations

A Strategic Data Foundation