Regions With Advanced UDI Submission Requirements
Unique Device Identification (UDI) regulations continue to evolve as regulatory authorities expand national and regional UDI databases, introduce new submission requirements, and extend implementation across additional device classes. While many jurisdictions have completed their initial UDI rollout, manufacturers must continue to navigate new compliance deadlines, transitional provisions, and ongoing data maintenance obligations as regulatory frameworks mature.
As organizations commercialize medical devices across multiple markets, keeping pace with changing UDI requirements has become increasingly complex. Each regulator establishes its own implementation timelines, submission processes, validation requirements, and data maintenance obligations, requiring manufacturers to monitor regulatory developments and maintain compliance across multiple jurisdictions.
This guide provides a consolidated overview of the latest UDI submission timelines across major regulated markets, helping organizations understand the current implementation status, key submission milestones, and ongoing regulatory obligations for maintaining UDI data.
This guide is intended for organizations responsible for planning, implementing, or managing global UDI compliance, including:
- IT and Integration teams responsible for UDI data integration, validation, and electronic submissions.
- Regulatory Affairs professionals responsible for global UDI strategy and regulatory submissions.
- UDI program managers coordinating multi-market implementation activities.
- Product Data Management, PIM, and Master Data Management teams responsible for maintaining compliant product data.
- Quality and Compliance teams supporting regulatory inspections, audit readiness, and data governance.
This Guide Covers
This guide provides a high-level overview of UDI database submission requirements across major regulated markets, including:
- The current implementation status of each regional UDI framework.
- Recent and upcoming UDI submission milestones.
- Transitional registration deadlines where applicable.
- The primary UDI databases and submission systems used by each regulator.
- Ongoing responsibilities for maintaining submitted UDI data.
- Summary timeline tables for each region to support implementation planning.
This Guide Doesn’t Cover
This guide is intended as an overview of regulatory timelines and should not be used as a substitute for the detailed regulatory requirements published by each health authority. It does not cover:
- General UDI labeling or direct marking requirements.
- Detailed data attribute or data model requirements for individual regulators.
- Technical submission specifications, APIs, or electronic messaging formats.
- Country-specific exemptions, enforcement discretion, or special regulatory pathways.
- Step-by-step submission procedures or onboarding activities.
- Detailed guidance on assigning UDI identifiers or implementing GS1, HIBCC, or ICCBBA standards.
Manufacturers should always consult the latest guidance published by the applicable regulatory authority when determining product-specific compliance obligations.
United States
Current Regulatory Status
The United States Food and Drug Administration established one of the first comprehensive national UDI frameworks through the Global Unique Device Identification Database.
The FDA implemented the UDI requirements through a risk-based rollout beginning with Class III and life-supporting or life-sustaining devices and subsequently extending the requirements to Class II, Class I, and unclassified devices.
The principal phased implementation dates have now passed. Manufacturers and other organizations that meet the FDA definition of a device labeler must submit required Device Identifier information to GUDID for devices within scope and maintain the accuracy of those records throughout the product lifecycle.
FDA regulations and guidance provide exceptions, alternatives, and enforcement policies for certain devices, including some Class I and unclassified consumer health products. Submission obligations must therefore be assessed according to the device classification, intended use, and applicable FDA policy.
| Date or Period | Devices | GUDID Submission Requirement |
|---|---|---|
| September 24, 2014 | Class III devices and devices licensed under the Public Health Service Act | Required Device Identifier information became subject to GUDID submission |
| September 24, 2015 | Implantable, life-supporting, and life-sustaining devices | Required Device Identifier information became subject to GUDID submission |
| September 24, 2016 | Class II devices | Required Device Identifier information became subject to GUDID submission |
| September 24, 2020 onward | Class I and unclassified devices | GUDID requirements became applicable, subject to FDA enforcement policies, exceptions, and alternatives |
| Ongoing | Newly introduced devices within scope | Create and submit the applicable GUDID Device Identifier record |
| Ongoing | Existing GUDID records | Update reportable device information and maintain accurate database records |
Current Submission Requirements
Before submitting data, the labeler must establish a GUDID account and identify the organization responsible for managing its records. Data may be entered through the GUDID web interface or submitted electronically using the FDA-supported HL7 Structured Product Labeling format.
Each record contains information associated with the Device Identifier, including the issuing agency, brand name, version or model, catalog number, device status, packaging configuration, storage and handling conditions, and applicable production-identifier characteristics.
A GUDID record must accurately correspond to the device and packaging configuration represented by its Device Identifier. When a change requires assignment of a new Device Identifier, a new GUDID record must be submitted rather than overwriting the identity of the existing device.
Existing records must also be maintained when reportable information changes. Records that are no longer commercially distributed remain part of the historical database and should be updated to reflect their current commercial-distribution status.
Key Takeaway
The United States UDI framework is fully operational across the principal device classes. Manufacturers must continue to submit accurate Device Identifier records to GUDID, maintain existing records, and manage changes in accordance with FDA requirements, exemptions, and enforcement policies.
European Union
Current Regulatory Status
The European Union UDI framework is established under the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation.
The framework includes the Basic UDI-DI, which groups devices that share the same intended purpose, risk class, and essential design and manufacturing characteristics, and the UDI-DI, which identifies a specific device model or configuration.
The European Database on Medical Devices serves as the central repository for UDI and device-registration information. Following the European Commission’s formal declaration that the first EUDAMED modules were functional, mandatory use of the Actor and UDI/Devices modules began on May 28, 2026.
| Date | Devices or Circumstance | EUDAMED Submission Requirement |
|---|---|---|
| Before May 28, 2026 | Eligible MDR and IVDR devices | Voluntary registration in the EUDAMED UDI/Devices module was available |
| May 28, 2026 | MDR or IVDR devices first placed on the EU market on or after this date | Register the device in EUDAMED before placing the first unit on the market |
| May 28, 2026 | Manufacturers, authorized representatives, importers, and system or procedure-pack producers | Use the mandatory EUDAMED Actor registration process |
| May 28–November 28, 2026 | Applicable Regulation and legacy devices already being placed on the market | Complete device registration during the six-month transition period |
| November 28, 2026 | Applicable devices covered by the transition | Final date for completing registration in the UDI/Devices module |
| Ongoing | Registered devices | Maintain current Basic UDI-DI, UDI-DI, device, manufacturer, and market-status information |
Devices First Placed on the Market After May 28, 2026
A device governed by the MDR or IVDR and first placed on the EU market on or after May 28, 2026 must be registered in EUDAMED before its first unit is placed on the market.
Manufacturers must first complete the applicable Actor registration and obtain a Single Registration Number. The device registration must then be created using the appropriate Basic UDI-DI, UDI-DI, European Medical Device Nomenclature code, classification, intended purpose, certificate, and device-characteristic information.
Transitional Device Registration
Applicable Regulation and legacy devices that were already being placed on the market when mandatory use began may qualify for the six-month transition period.
These devices must be registered in EUDAMED no later than November 28, 2026 when they continue to be placed on the market during the transition. The registration deadline applies to the device record rather than every individual unit placed on the market.
Ongoing Data Maintenance
Manufacturers must maintain accurate device information in EUDAMED throughout the commercial and regulatory lifecycle. Changes that affect the Basic UDI-DI or UDI-DI structure may require a new identifier and device registration, while other reportable changes must be reflected in the existing record.
The EUDAMED record must remain aligned with the device’s regulatory documentation, certificates, responsible economic operators, and current market status.
Key Takeaway
Mandatory use of the EUDAMED UDI/Devices module began on May 28, 2026. Manufacturers must register newly placed devices before market placement and complete applicable transitional registrations by November 28, 2026, while maintaining accurate Basic UDI-DI, UDI-DI, and device information.
Australia
Current Regulatory Status
Australia’s UDI framework is administered by the Therapeutic Goods Administration through the Australian Unique Device Identification Database.
Implementation follows a risk-based, phased approach beginning with higher-risk medical devices. Mandatory compliance began on July 1, 2026 for Class III and Class IIb medical devices, with lower-risk devices and in vitro diagnostic devices following in later phases.
| Date or Phase | Devices | AusUDID Submission Requirement |
|---|---|---|
| Before July 1, 2026 | Eligible medical devices | Voluntary submission to the AusUDID was available |
| July 1, 2026 | Class III medical devices | Submit required UDI records and link them to the applicable ARTG inclusion |
| July 1, 2026 | Class IIb medical devices | Submit required UDI records and link them to the applicable ARTG inclusion |
| Later phases | Class IIa and Class Is medical devices | Mandatory requirements begin under the subsequent implementation schedule |
| Later phases | Applicable IVD devices | Mandatory requirements begin according to the IVD implementation schedule |
| Ongoing | Submitted records | Maintain accurate device information and manage reportable changes |
Database Submission and ARTG Linkage
The Australian sponsor is responsible for submitting and maintaining UDI records in the AusUDID. Manufacturers provide the information necessary for the sponsor to satisfy the Australian requirements.
An AusUDID record must be linked to at least one relevant inclusion in the Australian Register of Therapeutic Goods. A record that has been created but not linked to an ARTG inclusion does not appear as an active public record and does not satisfy the applicable compliance obligation.
The submitted information includes the Primary UDI-DI, applicable packaging-level identifiers, brand and model information, device classification, nomenclature, clinical size information, production-identifier characteristics, storage and handling conditions, and other required device attributes.
Existing Devices
The TGA implementation framework includes transitional arrangements for devices already supplied in Australia before the applicable compliance date.
Sponsors must determine whether a device qualifies for a transition and ensure that new or changed devices meet the applicable submission requirements before supply. Where a device does not comply by the relevant date, the sponsor may need to use the TGA’s consent-to-supply process while completing the required UDI activities.
Key Takeaway
Mandatory AusUDID requirements began on July 1, 2026 for Class III and Class IIb devices. Sponsors must submit complete UDI records, link them to the correct ARTG inclusions, and maintain accurate data as additional device classes enter later implementation phases.
Switzerland
Current Regulatory Status
Swissmedic operates swissdamed as Switzerland’s national database for medical devices and in vitro diagnostic medical devices.
The UDI Devices module became available for voluntary registration on August 18, 2025. Mandatory registration began on July 1, 2026, with a general transition period through December 31, 2026.
| Date | Devices or Circumstance | swissdamed Submission Requirement |
|---|---|---|
| August 18, 2025 | Medical devices, IVDs, systems, and procedure packs | Voluntary device registration became available |
| July 1, 2026 | Devices placed on the Swiss market | Mandatory registration obligation began |
| July 1–December 31, 2026 | Devices qualifying for the general transition | Complete registration during the transitional period |
| From July 1, 2026 | Devices associated with a reportable serious incident, field safety corrective action, or trend | Register immediately; the general transition does not apply |
| December 31, 2026 | Devices covered by the general transition | Final date for completing registration |
| January 1, 2027 onward | Devices within scope | Complete registration before the applicable market activity |
| Ongoing | Registered devices | Maintain accurate and current device data |
Transition Period
The legal registration obligation began on July 1, 2026. However, applicable devices already placed on the Swiss market may be registered during the transition period ending December 31, 2026.
The transition does not apply when a serious incident, field safety corrective action, or reportable trend occurs after July 1, 2026. In these circumstances, the applicable device, system, or procedure pack must be registered immediately before the vigilance information is submitted.
Submission Responsibilities
Manufacturers and authorized representatives are responsible for registering applicable devices and maintaining the associated data.
The swissdamed record includes the Basic UDI-DI, UDI-DI, device and packaging information, nomenclature, classification, intended purpose, manufacturer, authorized representative, certificate, and market-status information.
Economic operators must also ensure that their Actor information and Swiss Single Registration Number are established before completing the applicable device registrations.
Key Takeaway
Mandatory registration in swissdamed began on July 1, 2026. Applicable devices must be registered by December 31, 2026, while devices associated with reportable vigilance events require immediate registration without access to the general transition period.
China
Current Regulatory Status
China’s UDI framework is administered by the National Medical Products Administration. The national UDI database contains Device Identifier information and associated product data submitted by medical device registrants and filing entities.
Implementation has progressed through several batches. Earlier phases covered selected high-risk devices, followed by all Class III devices and 103 categories of Class II devices.
In March 2026, the NMPA, National Health Commission, and National Healthcare Security Administration announced additional phases that will extend UDI requirements to all remaining Class II devices, all Class I in vitro diagnostic devices, and subsequently all remaining Class I medical devices.
| Date | Devices | NMPA UDI Database Requirement |
|---|---|---|
| Earlier implementation phases | Selected high-risk devices | UDI assignment and database-submission requirements became applicable |
| June 1, 2024 | All Class III devices and 103 designated Class II device categories | Required UDI implementation and database submission began |
| June 1, 2027 | All remaining Class II medical devices, including Class II IVDs | Upload the lowest saleable-unit DI, higher packaging DIs, and related data before commercial sale |
| June 1, 2027 | All Class I in vitro diagnostic devices | Upload the applicable DIs and related data before commercial sale |
| June 1, 2029 | All remaining Class I medical devices | Upload the applicable DIs and related data before commercial sale |
| Ongoing | Devices with changes to DI-related data | Update the national UDI database before the changed product is commercially supplied |
Database Submission Requirements
For devices produced on or after the applicable implementation date, the registrant or filing entity must upload the Device Identifier for the lowest saleable unit, the Device Identifiers for higher packaging levels, and the associated product data before commercial sale.
Submitted data must be truthful, accurate, complete, and traceable. Registrants and filing entities are responsible for maintaining and updating the information in the national database.
When data associated with the lowest saleable-unit Device Identifier changes, the database must be updated before the affected product is commercially supplied. When the change requires a new Device Identifier, the new identifier must be uploaded as a new database record.
For devices already registered before the applicable implementation date, the lowest saleable-unit Device Identifier must also be supplied through the registration-renewal, registration-change, or filing-change process, as applicable.
Key Takeaway
China continues to expand its UDI framework through phased implementation. Existing requirements already cover higher-risk devices, while all remaining Class II devices and Class I IVDs enter scope on June 1, 2027, followed by remaining Class I devices on June 1, 2029.
Brazil
Current Regulatory Status
Brazil’s UDI framework is established under RDC 591/2021 and administered by the National Health Surveillance Agency.
The regulation created a phased UDI framework and provided for the development of a national UDI database known as the Sistema de Identificação Única de Dispositivos, or SIUD.
SIUD became operational on March 1, 2026, when IN 426/2026 took effect. The instruction establishes requirements for creating, transmitting, maintaining, changing, and discontinuing UDI-DI records in the Brazilian database.
| Date or Status | Devices or Records | SIUD Submission Requirement |
|---|---|---|
| July 2025 onward | Devices reaching their applicable RDC 591/2021 implementation phase | Applicable UDI requirements began under the phased framework |
| March 1, 2026 | UDI-DIs within the operational scope of SIUD | IN 426/2026 data-submission and maintenance requirements became effective |
| Before market availability | Devices subject to an active UDI implementation phase | Submit the applicable UDI-DI and associated data to SIUD |
| Within the applicable regulatory timeframe | Existing SIUD records with reportable changes | Update or replace the UDI-DI record as required |
| Ongoing | Devices in later risk-based phases | Complete SIUD submissions as each applicable phase takes effect |
SIUD Data Submission
The operational scope of SIUD consists of data associated with the UDI-DI under RDC 591/2021. The database supports the creation and maintenance of device records and the management of relationships between packaging configurations.
Responsible organizations must ensure that the information submitted to SIUD corresponds with the applicable ANVISA device registration or notification and accurately represents the product supplied in Brazil.
When a change requires a new UDI-DI, the replacement operation must generally be completed in SIUD within 30 calendar days of publication of the corresponding regulatory change in Brazil’s Official Gazette.
Records must also be maintained when product information changes, a device is discontinued, or the relationship between Device Identifiers and packaging levels changes.
Key Takeaway
Brazil’s SIUD database became operational on March 1, 2026. Manufacturers must submit and maintain UDI-DI data in accordance with IN 426/2026 and the phased implementation schedule established under RDC 591/2021.
Saudi Arabia
Current Regulatory Status
The Saudi Food and Drug Authority operates the Saudi Unique Device Identification database, commonly referred to as Saudi-DI or Ramz.
The framework requires manufacturers or authorized representatives to submit and maintain the required information for medical devices subject to the Saudi UDI requirements.
Saudi Arabia implemented the framework through phased compliance dates based primarily on device risk classification. The principal implementation phases have passed, and Saudi-DI now operates as an established national device-identification database.
| Date or Status | Devices | Saudi-DI Submission Requirement |
|---|---|---|
| Completed implementation phases | Higher-risk medical devices | Submit the applicable UDI-DI and device information to Saudi-DI |
| Completed implementation phases | Lower-risk medical devices subsequently brought into scope | Complete the applicable Saudi-DI submission |
| Before applicable market supply | Newly introduced devices within scope | Register the UDI-DI and associated device information |
| Ongoing | Existing Saudi-DI records | Maintain accurate device, packaging, manufacturer, and market-status information |
| Ongoing | Devices affected by reportable changes | Update the existing record or submit a new UDI-DI where required |
Saudi-DI Submission Requirements
The manufacturer or authorized representative must submit the appropriate data for devices subject to the framework.
Records include the Device Identifier, issuing agency, brand and model information, packaging configuration, manufacturer, authorized representative, device classification, production-identifier characteristics, storage information, and other required metadata.
The organization responsible for the record must ensure that the Saudi-DI information remains aligned with the applicable Medical Device Marketing Authorization and the product supplied in Saudi Arabia.
Key Takeaway
Saudi Arabia operates an established UDI framework through Saudi-DI. Manufacturers and authorized representatives must ensure that required device and packaging information is submitted before applicable market supply and remains aligned with regulatory authorization data.
Singapore
Current Regulatory Status
Singapore’s UDI framework is administered by the Health Sciences Authority. UDI information is incorporated into the existing medical device registration and notification framework rather than managed exclusively through a separate public UDI database.
Class B, C, and D devices are registered through the Singapore Medical Device Register. Class A devices are exempt from full product registration but generally require product notification through the HSA’s submission system.
The UDI framework has been introduced through phased implementation based on device risk class. Manufacturers and registrants must provide the applicable UDI-DI information through the relevant registration, notification, or change process.
| Status or Phase | Devices | UDI Submission Requirement |
|---|---|---|
| Initial implementation phase | Class D medical devices | Provide applicable UDI information through the HSA registration framework |
| Subsequent implementation phase | Class C medical devices | Provide applicable UDI information through the HSA registration framework |
| Subsequent implementation phase | Class B medical devices | Provide applicable UDI information according to the applicable HSA implementation requirements |
| Applicable notification phase | Class A medical devices | Provide required product and UDI information through the Class A notification process |
| Ongoing | Newly registered devices | Include applicable UDI-DI information in the registration or notification |
| Ongoing | Existing registered or notified devices | Update UDI information through the appropriate HSA change-notification process |
Submission Requirements
For Class B, C, and D devices, the Singapore registrant must ensure that the applicable UDI-DI information is associated with the device’s registration in the Singapore Medical Device Register.
For Class A devices, the importer or manufacturer submits the applicable product notification through HSA’s submission environment.
UDI data must remain consistent with the device registration, labeling, manufacturer information, models or configurations, and packaging levels supplied in Singapore. Changes to the Device Identifier or other regulated product information must be managed through the applicable HSA notification or registration-change process.
Key Takeaway
Singapore manages UDI information through its existing medical device registration and notification framework. Manufacturers and registrants must provide and maintain UDI-DI data through the applicable HSA process based on device class and registration status.
South Korea
Current Regulatory Position
South Korea operates a mature UDI framework administered by the Ministry of Food and Drug Safety.
The framework combines UDI code registration, standardized device-information management, and supply reporting through the national Medical Device Information Portal and associated UDI tracking systems.
Implementation was introduced through risk-based phases beginning with Class IV devices and progressively extending to Classes III, II, and I. All principal device classes are now included in the operational framework.
| Status | Devices | Submission Requirement |
|---|---|---|
| Completed first phase | Class IV medical devices | Register the UDI code and standardized device information |
| Completed subsequent phases | Class III and Class II medical devices | Register the applicable UDI and device information |
| Completed final principal phase | Class I medical devices | Register the applicable UDI and device information |
| Before applicable distribution | Newly introduced devices | Complete required UDI code and standardized-information registration |
| Ongoing | Registered devices | Maintain accurate device, manufacturer, packaging, and identifier information |
| Ongoing | Supply transactions within scope | Submit required distribution or supply information through the applicable reporting system |
South Korea operates a mature UDI framework through the Ministry of Food and Drug Safety’s Medical Device Information Portal. The phased implementation across device classes has already been completed.
Submission and Supply Reporting
Manufacturers and importers must register standardized device information associated with the UDI-DI through the applicable MFDS system.
The national framework also supports reporting of device supply information, including the product, license or notification number, model, UDI code, lot or serial information where applicable, supplier, destination, quantity, and supply date.
UDI records must remain consistent with the device approval or notification and the configuration distributed in South Korea. Reportable product changes must be reflected in the applicable regulatory and UDI records.
Key Takeaway
South Korea has completed its principal risk-based UDI rollout. Manufacturers and importers must register standardized device information, maintain accurate UDI records, and comply with applicable supply and distribution reporting requirements.
Taiwan
Current Regulatory Status
Taiwan’s UDI framework is administered by the Taiwan Food and Drug Administration through the Taiwan UDI Database.
The TFDA introduced mandatory UDI requirements through phased schedules based on risk class and device category. Implementation began with higher-risk Class III devices and subsequently expanded to Class II devices and additional product categories.
Manufacturers and Taiwan license holders must submit and maintain applicable UDI data through the TFDA UDI information-management platform.
Taiwan Submission Timeline
| Status or Phase | Devices | TUDID Submission Requirement |
|---|---|---|
| Completed initial phase | Designated Class III medical devices | Submit applicable UDI-DI information to the Taiwan UDI Database |
| Completed subsequent phases | Additional Class III and designated Class II devices | Complete applicable UDI database submissions |
| Current implementation | Device classes and categories included in TFDA announcements | Submit and maintain required UDI information |
| Future phases | Additional Class I devices or other designated categories | Comply according to the effective dates established in TFDA announcements |
| Ongoing | Newly approved or registered devices within scope | Submit the applicable UDI-DI and associated data |
| Ongoing | Existing TUDID records | Maintain accurate device information and process reportable changes |
Database Submission
The responsible medical device firm must submit the applicable Device Identifier and associated device information to the Taiwan UDI Database.
The record can include the issuing agency, UDI-DI, Chinese and English product names, license or listing number, model, specification, packaging level, manufacturer, local license holder, production-identifier characteristics, and commercial status.
UDI information must remain aligned with the applicable Taiwan device license, listing, labeling, and product configuration. Changes that require a new UDI-DI must be submitted as a new record, while other reportable changes must be reflected in the existing database entry.
Key Takeaway
Taiwan’s UDI framework is operational for designated Class III, Class II, and other specified device categories. Manufacturers and local license holders must monitor TFDA announcements, submit required UDI data, and maintain alignment with device licenses and product configurations.
Japan
Current Regulatory Status
Japan’s UDI framework is administered through requirements and implementation guidance issued by the Ministry of Health, Labour and Welfare.
The framework combines standardized barcode identification with registration of device-identification information in an applicable product database. It supports product traceability, supply-chain efficiency, medical safety, reimbursement processes, and device information exchange.
Japan’s UDI framework is established and operational rather than undergoing a new risk-class implementation phase.
| Status | Devices | Database Submission Requirement |
|---|---|---|
| Established implementation | Medical devices and IVDs within the applicable framework | Register standardized product-identification information in the relevant database |
| Before commercial distribution | Newly marketed devices | Complete the applicable product and identifier registration |
| Before distribution of a changed product | Devices affected by reportable product or identifier changes | Update the existing record or create a new record as required |
| Ongoing | Commercially distributed devices | Maintain accurate device, packaging, barcode, and product information |
| Ongoing | Discontinued products | Update commercial-status information while preserving the historical record |
Database Registration
Manufacturers and marketing authorization holders must ensure that product identification information is registered in the applicable Japanese medical device database.
The information typically includes the GS1 product code, product name, model, packaging configuration, manufacturer or marketing authorization holder, regulatory approval or certification information, and other product characteristics.
The database record must correspond with the barcode or other automatic-identification carrier used on the device packaging. Product changes affecting the identifier or packaging hierarchy must be reflected in the database before the changed configuration is distributed.
Key Takeaway
Japan operates an established device identification and database registration framework. Manufacturers and marketing authorization holders must maintain accurate product, packaging, and identifier information in the applicable database before commercial distribution and following reportable changes.
Conclusion
Managing UDI Submissions Across Global Markets
Global UDI compliance requires organizations to manage different identifier structures, classifications, data models, code lists, submission methods, and regulatory timelines.
Although most frameworks are based on common international UDI principles, each regulator defines its own submission scope, required attributes, validation rules, packaging relationships, transition provisions, and change-management requirements.
Manufacturers operating across multiple markets must be able to:
- Identify which devices and packaging levels fall within each regulatory phase.
- Maintain the correct Basic UDI-DI, UDI-DI, and localized identifier relationships.
- Map product classifications and regulatory registrations to regional UDI requirements.
- Prepare complete device records using the required regional attributes and code lists.
- Validate records before submission to reduce errors and rejections.
- Link UDI records to the applicable regulatory registrations or market authorizations.
- Monitor submission acknowledgements, validation messages, and processing statuses.
- Update records when regulated product information changes.
- Create new records when changes require assignment of a new Device Identifier.
- Maintain complete submission histories and supporting audit records.
Key Takeaway
Successful compliance depends on more than meeting a single implementation date. Organizations must establish sustainable processes for preparing, validating, submitting, monitoring, and maintaining UDI data throughout the complete device lifecycle and across every market in which their products are supplied.
