How to Apply for a UDI and Enter it into the GUDID Database

Inquiry

The U.S. FDA has established the Unique Device Identifier (UDI) for medical devices to identify and regulate devices in the U.S. market from manufacturing to patient use. Medical device manufacturers exporting to the U.S. are required to apply for a product UDI within a specified period of time, and the packaging and labeling of the device must have a UDI code and be uploaded into the GUDID database (one of the important modules of the FDA database).

In this article, we introduce how medical device manufacturers should be compliant in applying for a UDI and entering it into the GUDID database.

Introduction of UDI

UDI is a system established by the FDA to uniquely identify medical devices in the healthcare supply chain. The UDI system is designed to establish a standardized "universal language" for manual and machine identification of devices to protect patient safety, enhance post-market surveillance, and improve patient safety. The UDI system is essential for tracking, identifying, and managing medical devices, especially in cases of recalls, adverse events, or inventory management.

UDI format

A UDI is a code that is either plain numeric or a combination of numeric and alphabetic characters. The code usually consists of the following two parts:

Device Identifier (DI)

The content is fixed and is used to identify the labeling machine as well as the model of the device.

Production Identifier (PI)

The content is variable and may contain the manufacturing lot number, date of manufacture, serial number, expiration date of the device, as well as unique device identifiers related to human cells and tissues.

Introduction of GUDID

GUDID (Global Unique Device Identification Database) is a global UDI database established by the FDA that collects and stores key information about medical devices identified through the UDI system. The GUDID database is designed to improve the informational tracking of medical devices, ensure device safety, and promote transparency and regulatory oversight in the medical device marketplace.

FDA requires manufacturers to submit their medical device UDIs and associated product information to GUDID for easy access by regulatory agencies and the public.

The general process for requesting a UDI and entering it into the GUDID database is as follows:

Select an FDA-approved issuer
Obtain a UDI from the selected issuer
Apply for DUNS and GMDN codes
Enter into the GUDID database

FDA-accredited UDI Issuer

FDA-accredited UDI Issuing Authorities include Globe Standard 1 (GS1), Health Industry Business Communications Council (HIBCC), and International Council for Commonality in Blood Banking Automation (ICCBBA). These agencies are authorized to review UID applications submitted globally and issue unique device identifiers for compliant companies in compliance with the FDA UDI rule.

GS1, HIBCC, and ICCBBA have their own UDI generation systems and may offer UDI standards for different types of medical devices. GS1 is the most widely used item code standard in the world and meets all current national and regional UDI requirements, so most medical device companies choose GS1 to apply for UDI. The following is an overview of the application process, using GS1 as an example.

Register for GS1 membership

Upon joining a GS1 member organization (e.g., GS1 US), a company receives the GS1 Company Prefix, which identifies the company. The GS1 Company Prefix is part of the data structure for all GS1 identifiers (e.g., GTIN, GLN) and provides the basis for generating all GS1 identifiers. Upon membership, companies will receive complete documentation on how to assign GTINs (DI) to their products and how to use GS1 Application Identifiers (PI).

Obtaining GS1 standardized barcodes

Estimate bar code requirements and costs

Each class of medical device requires a different UDI for each size, color, material, packaging, etc. Licensing fees depend on bar code requirements and estimated annual sales revenue.

Complete the online application

Estimated annual sales revenue, approximate number of products requiring barcodes, and company contact information are required.

Pay online or by mail

Payment of the initial registration fee will grant a one-year license. A small annual renewal fee will then be paid for continued use of the barcode prefix.

Create a barcode

The GS1 Company Prefix will be emailed to the organization within one business day after payment is received. Once the company prefix is obtained, you can begin generating barcodes using the online tool provided by GS1.

Generate UDI

Generate a UDI using GS1 standards.

Request for DUNS

DUNS (D-U-N-S Number) is a globally recognized, unique nine-digit identifier provided by Dun & Bradstreet to uniquely identify a business entity, equivalent to a corporate identifier. DUNS numbers are widely used in international commerce to validate and correlate information from different businesses.

The FDA uses DUNS to verify the identity of a business, so it is one of the requirements for applying for FDA registration.

After registering an account and filling out the form with information (business name, address, contact information, type of business, etc.), DUNS will send an email or confirm the company's information over the phone. It usually takes 2-3 weeks to submit and correct the information, and you will receive an official DUNS code if you are approved.

Visit Dun & Bradstreet Support Page - Submit Case to inquire about DUNS.

Apply for GMDN

GMDN (Global Medical Device Nomenclature) is a global system for standardized naming and classification of medical devices. GMDN codes consist of five numbers that represent five levels of specific information, such as the type, function, and construction of the device.

GMDN provides a uniform system of names and terminology codes to accurately describe the use and function of medical devices, facilitate industry communication, and promote the regulation and management of the global medical device market. The GMDN is usually required for registration of medical devices in the UK and the U.S. In particular, the GMDN code must be provided when registering with the MHRA in the UK.

Enter into the GUDID Database

The FDA requires that only DI be uploaded to the GUDID database, and that PI be retained by the manufacturer.

(1) Create a GUDID Administrator Account

After submitting your application online, you will receive an application form from the FDA.

(2) Login to the GUDID system with the administrator account

Note that the administrator account does not have the authority to enter UDI, you need to create a new sub-account to enter UDI, the master account can only be used to manage sub-accounts and view UDI information.

(3) Create a GUDID sub-account

Create a sub-account in the menu below the master account, enter the information and activate it by e-mail.

(4) Use the sub-account to enter product UDI information.

FDA offers two ways to submit data: the web interface or HL7.

Manual data entry through the GUDID web: Online submission of DI records for smaller quantities.
Submission of HL7 SPL files through the FDA eSubmission Gateway: Submission of DI records in an XML file that conforms to Health Level 7 (HL7) Structured Product Labeling (SPL). Ideal for high volume simultaneous submission of multiple records.

(5) Waiting for FDA review of UDI

Wait 2 to 4 weeks for FDA to review and release the entered UDI number.

To search for a published UDI: https://accessgudid.nlm.nih.gov/

Proregulations provides medical device companies with UDI filing solutions, as well as maintenance services after the UDI system is set up. If you are interested in our services or need more details, please contact us.