FDA GUDID compliance for medical devices
made easy.
Gathering the necessary documentation and applying compliance criteria to create Unique Device Identifiers (UDIs) can be time consuming, but Registrar Corp is here to help.
Components of a UDI
- UDIs are readable numeric or alphanumeric codes used to identify unique medical devices from specific device labelers.
- To create UDIs, labelers must submit device and product information to the Global Unique Device Identification Database (GUDID).
- UDIs have two parts, the Device Identifier (DI) and Product Identifier (PI).
- DI – Mandatory, fixed portion of a UDI that identifies the labeler and device version or model.
- Must be issued by an accredited FDA agency
- PI – Conditional, variable portion of a UDI that identifies one or more device characteristics or production information such as:
- Manufacturing or product date
- Expiration date
- Batch or lot number
- Serial number
- Additional identification codes
- DI – Mandatory, fixed portion of a UDI that identifies the labeler and device version or model.
- Together, the DI and PI allow for easy search and identification in the GUDID database.
Complying With UDI Requirements
Gathering and submitting information for medical device UDIs can be a complex process. Registrar Corp’s regulatory team is equipped to support you along the way so you can confidently comply with FDA UDI regulations.
5 Steps to UDI Compliance
1. Obtain a Data Universal Number System (DUNS) number
All device labelers must request a DUNS number from Dun & Bradstreet, which acts as a labeler identification number.
2. Appoint a regulatory contact
FDA requires device labelers to designate a point of contact for device information and to assure that the required UDI information is submitted.
3. Gather your UDIs
Separate UDIs are required for every version or model of a device and each device characteristic, such as size, color, packaging, material, and style.
4. Identify GMDN codes
Device labelers must identify a Global Medical Device Nomenclature (GMDN) code for each device submitted to the GUDID. GMDN codes are the international standard for describing specific devices.
5. Submit UDIs and device information to GUDID
Submit Your UDIs With Registrar Corp.
Companies may have to submit hundreds, even thousands of UDIs at any given time. That’s where we come in.
- Registrar Corp’s UDI services include:
- Regulatory Contact and account coordinator support
- Guidance on required data
- Requesting or obtaining GUDID account
- Submitting UDI to GUDID database
- Expert one-on-one guidance throughout the process
Get help with UDI/GUDID submissions.
Simply complete the form to get started.
