Certification and Registration
Global Unique Device Identification Database (GUDID) registration for medical devices
Category:
U.S. Medical Device UDI & GUDID Registration
What is a GS1 Company Prefix?
The GS1 Company Prefix (GCP), compliant with GS1 standards, is a unique number assigned to enterprises by GS1 US. It serves as the foundation of GS1 identification standards, including the Global Trade Item Number (GTIN) used for product identification and the Global Location Number (GLN) used for location identification.
What is a GTIN, or Global Trade Item Number?
GTIN stands for Global Trade Item Number. It is a unique numerical identifier assigned to products and is typically found beneath the UPC barcode. GTIN is the global standard for product identification.
What is a UPC?
UPC stands for Universal Product Code. It is one of the most widely used barcode systems worldwide and can be found on nearly every product sold in physical stores and online. Customers may require a UPC barcode to be placed on products or packaging.
What is the Difference Between a UPC and a GTIN?
GTINs, UPCs, and other barcode types are often confused as the same concept; however, they are different. A GTIN is a numerical identifier that uniquely identifies a product, while a UPC is the barcode format used to enable the GTIN to be scanned by barcode readers.
What is a GLN?
GLN stands for Global Location Number. It is an identification number issued by GS1 and is primarily used in electronic data interchange (EDI) to identify legal entities and physical locations. A GLN can be generated using a GS1 Company Prefix.
Unique Device Identifier (UDI)
The UDI consists of two parts:
Device Identifier (DI) — A unique numeric or alphanumeric code specific to a device version or model.
Production Identifier (PI) — A numeric or alphanumeric code that identifies manufacturing-related information of a device, which may include:
- Batch number;
- Serial number;
- Expiration date;
- Manufacturing date;
- For human cells, tissues, or cell- or tissue-based products (HCT/Ps) regulated as medical devices, manufacturers may use a unique identification code that links the HCT/P to its donor.
Therefore: UDI = DI + PI
The Unique Device Identifier (UDI) on a device label is presented in both human-readable text and machine-readable formats. The following example shows a UDI from GS1, one of the FDA-recognized issuing agencies, using a one-dimensional barcode as the machine-readable format.
Human-readable barcode: (01)12345678901234(17)140102(11)100102(10)A1234(21)1234
In the GS1 system, the numbers in parentheses indicate different components of the UDI.
Device Identifier (DI) - 12345678901234
Production Identifier (PI):
Expiration Date: 140102
Manufacturing Date: 100102
Batch Number: A1234
Serial Number: 1234
What is GUDID?
GUDID stands for the Global Unique Device Identification Database. It is a centralized database established by the FDA that contains detailed information on medical devices. GUDID was developed as part of the FDA Unique Device Identification (UDI) requirements and serves as the digital platform for UDI information of medical devices marketed in the United States.
The GUDID database is designed to identify and track medical devices marketed in the United States. It provides detailed information for each device, including manufacturer information, production information, intended use, safety considerations, and storage and handling requirements. The database is accessible to regulatory authorities, manufacturers, healthcare providers, insurance companies, and the public.
Requirements for Class I Medical Devices Submitting UDI Data to FDA GUDID
Class I devices, as well as devices that are not classified as Class I, Class II, or Class III, shall bear a permanent UDI marking directly on the device if the device is intended for multiple uses and is intended to be reprocessed before each use (§801.45).
On July 22, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance for labelers of Class I medical devices. To allow the industry to focus on maintaining high-quality Unique Device Identification (UDI) submissions and responding to COVID-19-related challenges, the FDA announced that it would not enforce the requirements for standard date formatting, UDI labeling, and GUDID data submission for Class I and unclassified devices until December 8, 2022, which was previously scheduled for September 24, 2022.
FDA Registration of Medical Device Establishments and Device Listing
Owners or operators of establishments that manufacture or distribute medical devices intended for use in the United States are required to register with the FDA annually. This process is known as establishment registration (Title 21 CFR Part 807).
In general, establishments required to register with the FDA must also list the devices manufactured at their facilities and the activities performed on those devices. If a device requires premarket submission before being marketed in the United States, the owner/operator must also provide the applicable FDA premarket submission number, such as 510(k), De Novo, PMA, PDP, or HDE.
Satisfy provides one-stop registration services for clients exporting medical devices to the United States, including FDA registration, UDI registration, and GUDID registration. Please contact SATISFY customer service for more information.
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