US · FDA GUDID · Device Identifier (DI)
GUDID Registration — We Enter Your DI Data in FDA’s Database
We prepare and register your existing DI records in FDA’s GUDID—so your public device data is complete and correctly entered.
We take your existing UDI information and product data and register the Device Identifier (DI) records directly in FDA’s Global UDI Database (GUDID) using your account. You stay the labeler and keep full control of UDI assignment and your GUDID login; we handle the data preparation and entry so your records are in the system and easy to maintain.
We do the GUDID data entry
DI records based on your existing UDI
Simple completeness checks
Public data easy to maintain
Get Your DI Records Properly Registered in GUDID
FDA’s Global UDI Database (GUDID) holds key device identification data for your products. As the labeler, you must register Device Identifier (DI) records that match what is on your labels and packaging. Those records are visible in AccessGUDID, so missing or incorrect data shows up publicly.
- GUDID stores the Device Identifier (DI) and key attributes; it does not store Production Identifier (PI) values, only whether PIs appear on the label.
- Labelers are responsible for submitting and maintaining DI records in GUDID.
- We use your existing DI values and product details and enter them in GUDID via your web account.
- You avoid wrestling with the interface and can show that your device data is registered and complete at the DI level.
What You Will Receive
The focus is simple: DI records entered into GUDID correctly and based on the data you provide.
GUDID DI Record Preparation
Preparation and support for UDI/Devices entries using your existing Basic UDI-DI, UDI-DI, UDI-PI, and Annex VI data. We structure your information for the module, highlight obvious inconsistencies, and guide you through entering and saving records in EUDAMED.
- Mapping of your existing UDI information (DI, issuing agency) to GUDID fields.
- Structuring basic device and packaging data (brand, model/version, packaging levels, key attributes) in a format GUDID expects.
- Short list back to you of any obvious gaps or inconsistencies to resolve before we enter the data.
GUDID Data Entry (Web Application)
Preparation and support for UDI/Devices entries using your existing Basic UDI-DI, UDI-DI, UDI-PI, and Annex VI data. We structure your information for the module, highlight obvious inconsistencies, and guide you through entering and saving records in EUDAMED.
- Entry of your DI records into GUDID using the FDA web application and your account.
- Completion of required fields and key conditional elements, based on your instructions and supporting data.
- Basic on-screen checks so GUDID accepts the entries (no separate HL7 SPL build or automation).
Simple Maintenance Guidance
Preparation and support for UDI/Devices entries using your existing Basic UDI-DI, UDI-DI, UDI-PI, and Annex VI data. We structure your information for the module, highlight obvious inconsistencies, and guide you through entering and saving records in EUDAMED.
- A short note on when you should update a DI (e.g., label changes, packaging changes, discontinuation) vs. deactivate it.
- A basic checklist you can re-use when adding new DIs in the future.
Scope: Data preparation and registration support only. We do not design your UDI structure, do not create or interpret Annex VI data for you, do not select issuing agencies, and do not act as a notified body, importer, or label designer. All core Annex VI content and identifiers come from your organisation.
Device records registered in EUDAMED using your own identifiers and data.
Label & IFU Confirmation
- Check that BRH identification appears correctly on labels and IFUs, as required.
- Support for electronic IFU portal upload where applicable.
- Basic alignment of regulatory text in labels/IFUs with the granted registrations/notifications.
Change & Revalidation Plan
- Categorize post-approval changes (approval-required, immediate implementation, non-reportable) under RDC 751/2022.
- Maintain a calendar and tracking logic for 10-year registration validity and revalidation.
- Outline a simple governance model so technical and commercial teams know when to involve the BRH.
Vigilance & Field Actions Routing
- Define who reports what, to whom, and when for Brazil-specific vigilance signals and field actions.
- Clarify timelines and roles for ANVISA notifications, customer communications, and follow-up reporting.
- Ensure vigilance documentation supports registration and labeling obligations.
How Our GUDID Registration Service Works
We keep the process straightforward: prepare the data, enter it in GUDID, and hand back a clear overview.
Prepare
- Confirm your GUDID account access (submitter/coordinator) and labeler role.
- Collect your UDI information (existing DI and issuing agency) and a product list with basic attributes and packaging levels.
Build DI Records From Your Data
- Map your UDI and product details into the GUDID data structure.
- Flag any missing essentials for you to confirm or correct.
Register in GUDID (Web App)
- Log into your GUDID web account and enter DI records on your behalf.
- Complete required fields and save the entries so they appear in GUDID and AccessGUDID.
Confirm & Hand Over
- Provide you with a simple list of DIs registered and key attributes entered.
- Share a short checklist for adding or updating DIs on your own going forward.
Label/IFU confirmation
Maintenance & vigilance
What We Need From You
We rely on you as the labeler for UDI choices and product facts; we handle the data entry.
- GUDID account details and confirmation that you can grant us access/use under your internal rules.
- Existing DI values and issuing agency (GS1, HIBCC, ICCBBA, etc.—you choose).
- Product list: brand name, model/version, packaging levels, and a few key attributes (e.g., sterile, single-use, kit/system).
- If we are updating existing DIs: a short change-log and confirmation that edits are allowed.
- A single regulatory/quality contact for data questions.
Consulting and documentation support only. We do not design UDI schemes, do not create Annex VI data, do not select issuing agencies, and do not act as a notified body, importer, or label designer. You remain responsible for UDI assignment, Annex VI content, technical documentation, and all formal submissions in EUDAMED.
Scope & Exclusions
We keep the service precisely defined so your internal team, Sobel, and your partners in Brazil understand who does what—and where additional services might be needed.
In Scope
- Consulting and documentation support for medical device market access and authorization in Brazil.
- Development of a Brazil-specific regulatory and market access strategy.
- Organization and structuring of a Brazil-ready documentation package based on your existing evidence.
- Alignment and regulatory review of core Portuguese label and IFU content.
- Coordination of roles and responsibilities with local Brazilian partners involved in regulatory processes.
Out of Scope
- Acting as a government authority or making regulatory decisions on behalf of ANVISA.
- Acting as your Brazilian Registration Holder (BRH) or equivalent local legal entity, unless contracted separately via a dedicated service.
- Laboratory testing or generation of new technical or clinical evidence.
- Full marketing translations, graphic label design, printing, and commercial artwork creation beyond regulatory text alignment.
Inputs We Need From Your Team
- Clear description of your devices, intended purpose, and key claims.
- Overview of models/variants and how you plan to position them in the Brazilian market.
- Available technical and regulatory documentation, including evidence and applied standards.
- Existing label and IFU content (or source text) to be aligned to Portuguese and to Brazilian expectations.
- Information on your current or planned local partners and legal representatives in Brazil.
- Internal timelines, priorities, and constraints for Brazil market entry.
Consulting and documentation support only. We do not design UDI schemes, do not create Annex VI data, do not select issuing agencies, and do not act as a notified body, importer, or label designer. You remain responsible for UDI assignment, Annex VI content, technical documentation, and all formal submissions in EUDAMED.
When You Need a Brazilian Registration Holder
Typical situations where appointing a BRH becomes essential for Brazil market access:
- You are a foreign medical device manufacturer without a Brazilian legal entity but want to place devices on the Brazilian market.
- You need a single, stable license holder that is not tied to any one distributor, so you can keep commercial options open.
- You want to file notifications/registrations under RDC 751/2022 and maintain them over time, including changes and revalidation.
- You need someone to be clearly identified on Brazilian labeling/IFU as the holder responsible before ANVISA.
- You want vigilance and field actions in Brazil to follow defined timelines and routing, without ad-hoc email chains.
FREQUENTLY ASKED QUESTIONS
No. You remain the labeler and own UDI design, code structure, and issuing-agency choice. We simply use the DI information you have already assigned and register it in GUDID.
No. This service is focused on straightforward GUDID web application entry. For HL7 SPL automation or large-volume integration, you would work with your internal IT team or a separate technical vendor.
Yes, as long as your account allows edits. You tell us what needs changing, we adjust the fields via the web interface, and save the updated record.
No. We do not design or change labels, barcodes, or artwork. Our role is to make sure the GUDID DI data reflects what you already have on the label.
No. GUDID is a data registry, not an approval or clearance. Registering DI records does not mean FDA has approved or cleared your device.
Short Glossary
- Labeler: The party who assigns the UDI and whose name appears on the device label; responsible for GUDID entries.
- GUDID (Global UDI Database): FDA’s database that stores device identification data for devices with UDIs.
- DI (Device Identifier): The fixed part of the UDI that identifies the labeler and device model/version.
- PI (Production Identifier): The variable part of the UDI (e.g., lot, serial number, expiration date); GUDID only records which PIs are on the label, not the values.
- AccessGUDID: The public search interface that displays GUDID device records.
Have Your DI Records Properly Registered in GUDID
If your devices carry a UDI but your DI records are not yet in GUDID—or are only partly entered—your public data is incomplete. We take the information you already have, build simple DI records, and register them in GUDID via your account so your device data is where it belongs: complete, visible, and easy to maintain.
Contact Us
We would love to speak with you.
Feel free to reach out using the below details.
