Global UDI
Management Software

for Medical Device Manufacturers

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, Swissdamed, AusUDID, NMPA, and others.

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

Schedule 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 models 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
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), Swissdamed (Switzerland), NMPA (China), AusUDID (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

Frequently Asked Questions

What is UDI software, and how does it support medical device manufacturers?

UDI software helps manufacturers maintain the device information used for regulatory submissions. With DDi’s Visu UDI, product and packaging teams can maintain the attributes they own, while regulatory affairs team checks each record against the requirements.

How does UDI GUDID software support FDA submissions?

UDI GUDID software helps device labellers prepare Device Identifier (DI) records for the FDA’s Global Unique Device Identification Database (GUDID). Visu UDI checks required attributes and supports electronic submission files in HL7 Structured Product Labelling (SPL) XML format. Labellers can also enter individual records through the FDA’s GUDID web application.

How does EUDAMED UDI software support device registration?

EUDAMED UDI software helps manufacturers prepare device records for the European database on medical devices. Regulatory teams can organise the Basic UDI-DI and associated UDI-DIs where applicable, check required attributes and generate XML. Reviewing validation results before submission gives the team an opportunity to correct incomplete or inconsistent records.

How does EUDAMED M2M software differ from bulk XML upload?

With bulk upload, a regulatory user takes the file prepared in EUDAMED UDI software and uploads it to the database. EUDAMED M2M software transmits records through a configured machine-to-machine connection and returns responses for review. The choice depends on submission frequency, existing systems and who will handle exceptions.

What information does a Unique Device Identifier contain?

Under the FDA framework, the Device Identifier identifies the labeller and a specific device version or model. The Production Identifier, when present, carries details such as a lot number, serial number or expiration date. GUDID uses the DI as the key to the device record and excludes individual production identifier values.

How do device registration requirements differ between the United States and the European Union?

For FDA submissions, UDI GUDID software organises the attributes reported for each DI. For European registration, EUDAMED UDI software prepares the applicable EU dataset, including relationships between device identifiers. Manufacturers can reuse common product information while applying the data structure and validation rules required by each database.

Which UDI software option fits our organisation?

For a small portfolio maintained in Excel, DDi offers a pay-per-use portal for validation and file conversion. Teams that need a shared device record can use Visu UDI’s master data management option. Manufacturers with established ERP or PLM systems can connect those sources and configure a submission gateway.

How does Visu UDI identify errors before submission?

Validation follows the rules of the receiving database. UDI GUDID software checks the attributes needed for an FDA record. EUDAMED UDI software applies the corresponding European checks. If a required packaging attribute is missing, for example, the responsible team can correct the source value before generating the file.

Can UDI software integrate with ERP, PLM and labelling systems?

Yes. Visu UDI can bring device attributes from enterprise systems into the regulatory workflow. During implementation, teams identify which system owns each attribute and where corrections belong. For European submissions, EUDAMED M2M software can connect that workflow to the receiving database through a configured gateway.

What role does master data management play in UDI software?

Master data management gives product, packaging and regulatory teams a shared record. When packaging updates an attribute, regulatory staff can review the same value for use in EUDAMED UDI software and other submission workflows. Clear ownership reduces the work of reconciling conflicting spreadsheet versions.

Which submission steps can Visu UDI automate?

Depending on the deployment, Visu UDI can detect source-data changes, run market-specific checks and generate submission files. For a configured European connection, EUDAMED M2M software also handles transmission and acknowledgement tracking. Regulatory staff can then investigate returned errors and prepare corrections.

How does centralised UDI software help teams maintain records across markets?

A central record lets teams reuse device attributes and preserve the fields unique to each market. For a device sold in both markets, regulatory staff can use UDI GUDID software to prepare the FDA record and EUDAMED UDI software to prepare the European record from the same maintained source.

How does UDI support traceability during a recall?

The Device Identifier helps teams identify the affected version or model. If a recall covers specific lots or serial numbers, the production information on the label helps distinguish affected units. Capturing those identifiers in inventory, distribution or clinical records allows staff to locate stock and act on the recall notice.

What determines how long a UDI software implementation takes?

The timeline depends on source-data quality, portfolio scope and integration needs. A rollout of EUDAMED UDI software can begin with representative device records to establish field mapping and validation requirements. Adding EUDAMED M2M software also requires connection setup, transmission testing and agreement on who will review responses.

How does Visu UDI manage changes after the initial submission?

When device data changes, UDI software helps regulatory teams identify affected records. Teams can prepare the FDA update in UDI GUDID software and the corresponding European update in EUDAMED UDI software where required. With the gateway configured, EUDAMED M2M software returns acknowledgements and errors so staff can follow up.

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Related Blogs

Global Specific UDI Requirements by Countries

Australia (TGA)

2022 Jun – AUSUDID sandpit (beta) — general use, testing	On November 27, 2024, TGA deployed a significant enhancement package to the AusUDID Pre-Production environment. The Pre-Production version is now open again for sponsor use and feedback. Machine-to-Machine (M2M) submissions are still being tested Read more…
2023 Jan – Regulations and Guidance — in effect	As of 12th December 2024, the Therapeutic Goods Administration (TGA) has published the draft guidance document titled Complying with the Unique Device Identification regulations for medical devices for external review. Read more…
2026 Jan –Class IIb, III	NA
2026 July – Mandatory Compliance (implants)-UDI labeling, UDI data (Implementation timeframes and compliance dates will be published as soon as they are confirmed)	NA
Approach: similar to EU regulation; UDI/Device registration and UDI labels implemented by MD and IVD classes	The UDI must be on the label of a medical device. Australia is accepting labels that are compliant with European Union (EU) and United States (US) UDI Regulations, provided the device and its label are also compliant with Australia’s medical device regulations. UDI labelling requirements
UDI Data: ‘EU-like’ attributes reported to AusUDID	NA
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)	Australia’s TGA has updated the AusUDID system and related submission tools to improve usability and data accuracy. Key changes include enhanced screen flow, better error prompts, and improved GMDN browsing. The Bulk Upload Template (v2.9) now supports AutoFilter and no longer requires manufacturer name validation. HL7 SPL tools were revised with IP whitelisting guidance and relaxed name checks. NPC submissions now allow multiple GLNs per sponsor. Minor updates affect terminology and DI matching logic across all methods. All users must adopt the latest templates and documentation for compliance. Read more..
UDI Label: HRI & AIDC; Direct Mark	NA
STD: GS1/HIBCC/ICCBBA, EMDN/GMDN?	NA
2025 Mar – UDI Framework Registered	On 24 Mar 2025, Australia’s UDI regulatory amendments were registered on the Federal Register under Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025. Read more
2025 – UDI Support Tools and Resources	As of March 2025, TGA has published a comprehensive suite of resources for UDI compliance, including: UDI Guidance, Implementation Timing Guidance, Data Dictionary, Bulk Upload Template, Glossary, and infographics. Also includes details on sponsor obligations, device-specific requirements, and submission access via AusUDID. Read more…

Brazil (ANVISA)

2020 Jun – UDI Barcode inserts required in a few implant product packages; UDI data reported to RNI by healthcare provider	As of January 10, 2022, Brazil’s National Health Surveillance Agency (ANVISA) implemented the Unique Device Identification (UDI) system through Resolution RDC 591/2021. This regulation mandates that certain high-risk medical devices, including coronary artery stents and hip and knee arthroplasty implants, incorporate UDI barcodes on their packaging to enhance traceability and patient safety Read more…
2021 Feb – UDI System Publication	The amendment was published in RDC 884/2024 on June 1, 2024, and is already in force. Read more…
10 July 2025-Class IV (highest-risk) devices	NA
10 January 2026-Class III (high-risk) devices	NA
10 January 2027-Class II (Moderate-risk) devices	NA
10 January 2028-Class I (Low-risk) devices	NA
Approach: Pilot started with package UDI barcodes on Coronary Artery Stents and Hip & Knee Arthroplasty Implants	NA
UDI Data: Few attributes reported by healthcare provider to National Implant Registry (RNI)	NA
UDI Label: DI, Expiry Date, Lot/SN in AIDC (1D or 2D barcode) on (3) Mfr-supplied “Traceability Labels” with product pkg	NA
STD: GS1/HIBCC, ICCBBA	NA

Canada (Health Canada)

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

China (NMPA)

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

European Union (EC)

2020 Dec 01 — Actor Voluntary Economic Operator Registration	NA
Currently EUDAMED is voluntary, and its mandatory use date has been postponed multiple times.	As from 28 May 2026 the UDI/Devices module is mandatory to use. Read more…
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	NA
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	NA
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	NA
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.	NA
UDI Data: 109 attributes to EUDAMED; New BUDI-DI group concept	NA
Data Sub: Website entry/upload or electronic XML (via Data Exchange) to EUDAMED	NA
UDI Label: HRI & AIDC by class (III-2021, IIa/b-2023, I-2025); Direct Mark by class (Label + 2yr)	NA
STD: GS1/HIBCC/ICCBBA/IFA; SRN; EMDN	NA
Master UDI-DI	This is a recent regulatory addition introduced via: Reg. (EU) 2023/2197 (Contact lenses) Draft Reg. (EU) Apr 2025 & June 2025 (Spectacle lenses, frames) MDCG 2024-14 and 2025-XX guidance documents (in progress). It’s meant to reduce the reporting burden for highly individualized devices. Read more…

Japan (PMDA)

Ordinance No 128 of 2022-Guideline for Labeling of Codes on Containers to Identify Medical Devices, In Vitro Diagnostics, etc.	NA
04 Dec 2019 – PMD Act required barcode labels and registration	NA
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.	NA
Approach: Report device info to database and apply barcode to labels for medical devices and IVDs; future UDI reporting to UDI database	NA
UDI Data: Device registration includes: Product Code (DI), Expiry Data, Lot #, Serial #	NA
UDI Label: HRI and AIDC (1D GTIN-128 barcode symbol or 2D); no Direct Marking now	NA
STD: GS1	NA

Saudi Arabia (SFDA)

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

Singapore

1 Nov 2022 High-risk implantable (3) All Coronary stents, orthopedic joint replacement implants, and intraocular lens	NA
1 Nov 2024 Class D (High-risk) General medical devices and IVDs	NA
1 Nov 2026 Class C (Medium-risk) General medical devices and IVDs	NA
1 Nov 2028 Class B (remaining) General medical devices and IVDs	NA
Voluntary Class A (low-risk)	NA
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	NA
Data Sub: Website XLS upload	NA
UDI Label: HRI & AIDC; Direct Mark	NA
STD: GS1, HIBBC, ICCBBA	NA

South Korea (MFDS)

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

Taiwan

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

UK (MHRA)

2021 Jan 01 – Brexit effective, Guidance released	NA
2021 Jan 01 – UK-mfg Class I, Custom, IVD register	NA
2021 May 01 – III, II Implantable, Active Implantable, IVD A register	NA
2021 Sep 01 – IIB other, IIa, IVD B, IVD Self-test register	NA
2022 Jan 01 – OUK-mfg Class I, Custom, IVD register	NA
2023 Jul 01 – CE replaced by UKCA mark; Legislation expected to require UDI	NA
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	NA
UDI Data: ~70 attributes similar to EU reported to DORS (Device Online Reg. System) includes BUDI-DI	NA
Data Sub: Website manual entry or XLS upload (1,000 max records); perhaps future machine-to-machine	NA
STD: GS1/HIBCC/ICCBBA/IFA; GMDN, UKCA	NA

United States (FDA)

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	NA
2016 Sep – Class III Devices as a permanent marking on the device that are intended to be used more than once and reprocessed before each use 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	NA
2016 Sep – Class II Devices Required to bear UDI on the Device Contain Standard date format Provide UDI on stand-alone software device must be submitted to the GUDID database	NA
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	NA
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	NA
2022 Dec – Class I and unclassified devices, other than I/LS/LS devices UDI must be submitted to the GUDID database.	NA
Class I CGMP-exempt devices are excepted from UDI requirements.	NA
Approach: Report UDI Data & apply UDI to Labels by class	NA
UDI Data: 57 attributes to GUDID	NA
Data Sub: Website entry or electronic HL7 SPL (via ESG)	NA
UDI Label: HRI & AIDC; Direct Mark	NA
STD: GS1/HIBCC/ICCBBA; DUNS; GMDN/FDA	NA
Unique Device Identifier Requirements for Combination Products	US FDA issued a draft guidance entitled “Unique Device Identifier (UDI) Requirements for Combination Products Guidance for Industry and FDA Staff DRAFT GUIDANCE” (June 2025) FDA published the final guidance ‘Unique Device Identification (UDI) Requirements for Combination Products’, clarifying UDI labeling, direct marking, and GUDID submission requirements for combination products (co-packaged, single-entity, and cross-labeled) Read more..

Global UDI Management Software

Evolving Global UDI Regulations

A Strategic Data Foundation

Choose from 3 models that fit your business requirements and budgets

Few Products and you just need XML/XLS conversion:

If you do not have master data and other tools currently

If you have PLM/ERP and other systems

Other Salient Features

1. Compliance you can count on

2. Seamless EUDAMED Submission & Global Gateways

3. Advanced Regulatory Data Validation

4. Integrated Master Data Management (MDM) / RIM

5. Flexible UDI Integration

The DDi Advantage: Visu UDI

Future-Proof Your UDI Strategy Today

Frequently Asked Questions

What is UDI software, and how does it support medical device manufacturers?

How does UDI GUDID software support FDA submissions?

How does EUDAMED UDI software support device registration?

How does EUDAMED M2M software differ from bulk XML upload?

What information does a Unique Device Identifier contain?

How do device registration requirements differ between the United States and the European Union?

Which UDI software option fits our organisation?

How does Visu UDI identify errors before submission?

Can UDI software integrate with ERP, PLM and labelling systems?

What role does master data management play in UDI software?

Which submission steps can Visu UDI automate?

How does centralised UDI software help teams maintain records across markets?

How does UDI support traceability during a recall?

What determines how long a UDI software implementation takes?

How does Visu UDI manage changes after the initial submission?

Regulatory Information Management (RIM)

Regulatory Impact Assessment (RIA)

EUDAMED Software and Consulting

Legacy Device UDI Submissions: Issues, Risks and Recommended Best Practices

UDI Packaging Data Challenges: How to organize

Master Data Management: Essential Strategies for Medical Device/IVD Manufacturers

Global Specific UDI Requirements by Countries

Australia (TGA)

2022 Jun – AUSUDID sandpit (beta) — general use, testing

2023 Jan – Regulations and Guidance — in effect

2026 Jan –Class IIb, III

2026 July – 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?

2025 Mar – UDI Framework Registered

2025 – UDI Support Tools and Resources

Brazil (ANVISA)

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

Canada (Health Canada)

2022 – Proposal Health Canada UDI

Approach: Ongoing UDI preparation, expected to follow IMDRF UDI recommendations

China (NMPA)

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.

European Union (EC)

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

Direct marking of the reusable devices

Placing UDI-carriers on the labels of IVDs

Global UDI
Management Software