USA Market
UDI Consulting Services
Medical Device
IVD
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What is UDI Consulting Services?
UDI (Unique Device Identifier) Consulting services are offered to medical device manufacturers to assist them in implementing and complying with the UDI system mandated by the U.S. Food and Drug Administration (FDA). The UDI system is designed to enhance patient safety, streamline device tracking and recalls, and improve the accuracy and efficiency of adverse event reporting.
Why is UDI Consulting Services important?
Compliance with UDI regulations is mandatory for most medical devices in the United States. Failure to comply can lead to regulatory action, recalls, and legal consequences.
UDI Consulting Service is important for various reasons such as:
- Regulatory Compliance
- Patient Safety
- Supply Chain Efficiency
- Global Market Access
- Adverse Event Reporting
- Product Differentiation
Steps for UDI Submission:
- Obtain the DUNS number.
- Validate labeler information.
- Assign regulatory contract .
- Request GUDID (Global Unique Device Identification Database) account.
- Verify GMDN standard codes.
- Validate UDIs.
- Submit UDIs & device information to GUDID.
Process Flow for UDI Consulting Services
Client Assessment
Regulatory Research
Data Collection
UDI Classification
Database Registration
UDI Submission
Quality System Integration
UDI Maintenance
Post Compliance Support
Audits and Inspections
Market Expansion
How can we help in UDI Consulting Services?
The CliniExperts’ professionals will:
UDI enhances patient safety by allowing for accurate and rapid identification of medical devices, improving traceability in the event of recalls, and facilitating post-market surveillance.
Streamline supply chain operations, reduce errors, and improve inventory management.
Help manufacturers navigate global UDI regulations and expand their market presence.
Facilitates more accurate and efficient reporting of adverse events and helps the FDA and manufacturers respond to safety concerns.
Regulatory requirements for UDI Consulting Services
Documents
UDI consulting services may involve the review and preparation of various documents related to UDI compliance, including:
- Device identification and labeling strategies
- UDI data submission to the GUDID
- Labeling design and content
- Compliance with UDI labeling regulations
- Assessment of the UDI requirements applicable to specific devices
Timeline
The timeline for UDI consulting services can vary depending on the specific needs of the manufacturer and the complexity of the UDI implementation process. Manufacturers typically engage with UDI consultants as early as possible to ensure compliance with UDI requirements, but the timeline for UDI implementation may vary based on factors such as the number of devices, labeling changes, and other considerations.
Regulatory Body
The regulatory body responsible for UDI regulations in the United States is the U.S. Food and Drug Administration (FDA). The FDA has established UDI requirements to improve the tracking and tracing of medical devices throughout their lifecycle. While UDI consultants are not regulatory bodies themselves, they assist manufacturers in complying with FDA UDI regulations.
Fees
Assessment Determining if UDI/ GUDID submission Needed, Free
- GUDID Account, 395 USD
- First UDI Submission 395 USD
- Each additional UDI 195 USD
- GUDID Verification and Interim Updates, Free
Validity
The UDI system remains valid as long as the client continues to manufacture and market the medical devices in compliance with UDI requirements.
