UDI WORLD · MARKET GUIDE
UDI worldwide: authorities, databases and deadlines
Which UDI requirements apply in your target markets? This Europe IT Consulting guide compares 14 markets by authority, database and implementation status. It shows where obligations already apply, which next steps have been announced and where a binding implementation date has not been established.
UDI worldwide does not mean registering once and being finished everywhere. Device identification, labelling and data submission must fit the target market. EUDAMED, GUDID, swissdamed and AusUDID have their own requirements. A market overview therefore replaces neither a device-specific assessment nor its market registration.
Markets at a glance
The status describes the system, not the complete compliance of every device. The country sections below explain scope, exceptions and sources.
| Market | System / database | Status |
|---|---|---|
| European Union | EUDAMED | Mandatory use started |
| Switzerland | swissdamed | Registration with transition period |
| United Kingdom | MHRA | Distinguish GB and Northern Ireland |
| Türkiye | ÜTS | A separate ÜTS process |
| United States | GUDID | UDI system in use |
| Brazil | SIUD | SIUD available since March 2026 |
| Canada | UDI / MDALL | Mandatory start not established |
| China | NMPA UDI | Expansion in 2027 and 2029 |
| Singapore | SMDR / MEDICS | Class C: next phase in 2026 |
| Japan | GTIN / Barcode | Barcode requirements in force |
| South Korea | MFDS UDI | UDI and traceability operational |
| Taiwan | TUDID | Classes II and III covered |
| Saudi Arabia | Saudi-DI | UDI and Saudi-DI |
| Australia | Australian UDI Database (AusUDID) | Phased from July 2026 |
Europe
European Union
Europäische Kommission / European Commission
Mandatory use started
Mandatory use of the first four EUDAMED modules began on 28 May 2026, including UDI/Devices. Device-specific transition rules still matter. This is neither a new universal UDI labelling deadline nor the launch of all six modules.
Medical devices: I, IIa, IIb, III · IVDs: A–D
Official sources: European Commission: EUDAMED
Switzerland
Swissmedic
Registration with transition period
Device registration became mandatory on 1 July 2026, with a transition period ending on 31 December 2026. Reportable serious incidents, field safety corrective actions or trends can require immediate registration. Actor registration and device registration are separate tasks.
Medical devices: I, IIa, IIb, III · IVDs: A–D
Official sources: Swissmedic: swissdamed
United Kingdom
MHRA
Distinguish GB and Northern Ireland
For Great Britain, the May 2026 draft proposes UDI requirements. A draft does not establish a binding implementation date. Northern Ireland follows the applicable EU MDR/IVDR framework. A blanket statement that the UK has not introduced UDI would therefore be misleading.
Scope: assess GB and Northern Ireland separately
Official sources: MHRA: draft regulations 2026 · MHRA: Northern Ireland
TR
Türkiye
TİTCK / T.C. Sağlık Bakanlığı
New in this overview
A separate ÜTS process
Türkiye uses the Ürün Takip Sistemi (ÜTS). Product and company registration and traceability require process-specific assessment. The registration guide announced in June 2026 provides a starting point for checking applicable requirements. ÜTS is not an EUDAMED module.
Assess product registration and traceability separately
Official sources: Sağlık Bakanlığı: ÜTS registration guide 2026
Americas
United States
FDA
UDI system in use
UDI labelling and GUDID data requirements are established, subject to exemptions and device-specific provisions. GUDID contains identification and device information, not the actual production values of every batch. The earlier September 2023 reference was not a universal implementation deadline for all devices.
Risk classes: I, II, III
Official sources: FDA: UDI compliance policies · FDA: UDI basics
Brazil
Anvisa
SIUD available since March 2026
The SIUD database has operated since 1 March 2026. Labelling, data submission and vigilance follow different deadlines. A single “UDI data import 2024–2028” table does not correctly represent these obligations. Refer to RDC 591/2021, IN 426/2026 and current Anvisa information.
Risk classes: I–IV · Check each obligation separately
Official sources: Anvisa: UDI and current deadlines · Anvisa: SIUD documentation
Canada
Health Canada
Mandatory start not established
The official 2021 UDI consultation has closed. A binding national UDI implementation date was not established by the primary sources reviewed. The earlier proposal does not justify describing MDALL as an already implemented UDI database.
Risk classes: I–IV · A proposal is not a mandate
Official sources: Health Canada: UDI consultation
Asia & Middle East
China
NMPA
Expansion in 2027 and 2029
UDI already covers class III and selected class II devices. Newly manufactured devices across class II, including IVDs, and class I IVDs enter scope on 1 June 2027; remaining class I devices on 1 June 2029. Earlier obligations and specified exemptions remain applicable.
Risk classes: I, II, III · Manufacturing date matters
Official sources: NMPA: Notice 21/2026 (Shanghai authority) · Beijing authority: implementation update 2026
Singapore
Health Sciences Authority (HSA)
Class C: next phase in 2026
HSA’s phased schedule specifies 1 November 2026 for class C and 1 November 2028 for class B. Class D has been covered since November 2024, selected implants since 2022. UDI remains voluntary for class A. HSA reserves the right to adjust the schedule.
Risk classes: A–D · Consider labelling and data maintenance
Official sources: HSA: guidance documents (GN-36) · HSA: GN-36 R2, pp. 40–41 (PDF)
Japan
MHLW / PMDA
Barcode requirements in force
MHLW barcode identification requirements have applied since 1 December 2022, with device-specific exceptions. They address GTINs and packaging levels. Assess labelling and national information processes separately; Japan should not simply be treated as another GUDID or EUDAMED implementation.
Risk classes: I–IV
Official sources: MHLW: barcode identification requirements
South Korea
Ministry of Food and Drug Safety (MFDS)
UDI and traceability operational
The MFDS portal combines UDI-related device information with supply and traceability functions. Device data registration and supply reporting are separate tasks. Earlier phase dates for supply reporting should not be presented as universal UDI labelling implementation dates.
Risk classes: I–IV
Official sources: MFDS: UDI integrated information portal
TW
Taiwan
Taiwan Food and Drug Administration (TFDA)
New in this overview
Classes II and III covered
UDI phases cover class III implants from 1 June 2021, other class III devices from 1 June 2022 and class II from 1 June 2023. Requirements are tied to manufacturing dates; specific exemptions must be considered.
Covered risk classes: II, III
Official sources: TFDA: UDI implementation announcement
Saudi Arabia
Saudi Food and Drug Authority (SFDA)
UDI and Saudi-DI
MDS-REQ 7 governs UDI labelling and Saudi-DI data maintenance for covered devices. Manufacturers or authorised representatives must ensure UDI-DI data are available when devices enter the market. UDI does not replace other labelling or marketing authorisation. Scope includes exemptions.
Risk classes: A–D
Official sources: SFDA: MDS-REQ 7, version 4 (PDF)
Oceania
Australia
Therapeutic Goods Administration (TGA)
Phased from July 2026
UDI obligations start for classes III and IIb on 1 July 2026, followed by IIa in 2027. Class Is and covered class 3/4 IVDs follow in 2028; covered class 1/2 IVDs in 2029. AusUDID data and UDI labelling do not replace required ARTG inclusion.
Medical devices and IVDs: check scope and exemptions
Official sources: TGA: UDI implementation · TGA: scope and exemptions
From market overview to a reliable data process
Keep four decisions separate when planning your project. This turns a list of target markets into a traceable submission process.
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Data source
Where are the device data: Excel, SAP, ERP or a database?
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Europe IT solution
GSP for the portal workflow, GUDI for UDI data management in SAP, or project support.
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Transfer method
The technical method depends on the authority and solution. M2M is not another product name.
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Operating model
One-time submission or ongoing maintenance: assign approval, feedback review and correction responsibilities.
Multiple target markets. A well-planned starting point.
Europe IT Consulting supports data preparation, validation and UDI submission. In GSP, the customer uploads the completed Excel template, reviews validation results and initiates transmission. With GUDI, the customer manages and submits UDI data from SAP and can process authority feedback.
The 14 markets in this guide are not a promise of 14 available software modules. The authority module, data scope and workflow are agreed for your project.
Frequently asked questions about UDI worldwide
Is there one worldwide UDI database?
No. This guide covers different national and regional systems. Even where device identifiers can be reused, data fields, responsibilities and submissions remain market-specific.
Are labelling and database deadlines the same?
Not automatically. Assess UDI on labels or devices, database submission, direct marking and regulatory transition periods as separate obligations. EUDAMED and Brazil illustrate why a single year is not enough.
Does UDI submission provide marketing authorisation?
No. Submitting UDI data is not equivalent to marketing authorisation or a complete regulatory assessment of a device.
How current is the country information?
The cited primary sources were reviewed on 4 September 2026. Drafts and older consultations are clearly identified where these are the available evidence. Check current authority requirements again before a specific submission.
