Medical Device Labeling & UDI

    

Global Regulatory Affairs Consulting Agency, KGMP CORP.

Medical Device Labeling & UDI

Partner with KGMP to ensure your products comply with the regulatory standards of your target market.

KGMP is a trusted leader in medical devices consulting, providing expert guidance to navigate market-specific requirements and ensure compliance with local and global regulations, facilitating safe export and distribution.

Medical Device Label & UDI Compliance: Essential Insights for Your Business

Understanding medical device labeling regulations is crucial for manufacturers and distributors. The label contains essential information on the safe use of medical devices, helping consumers understand the intended use and precautions necessary for safe operation. Also, medical device labels and packaging must include a Unique Device Identification (UDI) for accurate tracking, distribution monitoring, and standardized documentation in electronic health records (EHR).

Strict labeling regulations apply in many countries, and non-compliance can lead to fines, legal issues, recalls, and market entry delays.

KGMP Medical Device Label Review Service

Classification & Device code	Mandatory Requirements & UDI	Label Format	Marketing Claims

Key Stage of Label Review

We provide label review services that ensure compliance with regulatory requirements, focusing on ingredient suitability and labeling accuracy to prevent penalties for mislabeling.

Our team cross-references your ingredients and labels with extensive regulations, guidance, and warning letters from relevant authorities in your target country to ensure compliance. With our expert reviews, you can simplify your path to global markets and ensure your products meet the highest standards. Our expertise in various global regulations helps you avoid costly delays and mitigate the risk of detention before shipping.

 

Medical Device Label Review Includes:

ㆍ      Format, font size, the order and place of declarations

ㆍ      Mandatory requirements such as identity, net quantity, business information, intended use, adequate directions, warnings, country of origin, expiration date, batch number, UDI, and etc.

ㆍ      Marketing claims such as product functional, and etc.

 

UDI Service Includes:

ㆍ      Identifying and selecting accredited UDI issuing agencies

ㆍ      Ensuring accurate UDI data formatting for seamless GUDID submission

ㆍ      Offering guidance on supply chain coordination and validation for UDI compliance

ㆍ      Comprehensive support tailored to your UDI implementation needs

 

Understanding the US FDA UDI/GUDID System

U.S. FDA UDI compliance goes beyond merely marking a device with a number or adding a barcode to its label. It requires meeting multiple regulatory requirements. Each UDI consists of two key elements:

Device Identifier (DI): Specifies the device model/version and manufacturer.

Production Identifier (PI): Includes details such as lot or batch number, serial number, expiration date, and other manufacturing data.

UDI Requirements by medical device class:

ㆍ      Class I devices require only a Device Identifier (DI).

ㆍ      Class II and III devices must include both Device Identifier (DI) and Production Identifier (PI).

ㆍ      Additional Compliance Considerations:

ㆍ      UDI numbers must be obtained from U.S. FDA-accredited issuing agencies.

ㆍ      All medical devices sold in the US must include UDI information on labeling and packaging.

ㆍ      Reusable devices that require reprocessing between uses must have UDI data permanently marked on the device.

ㆍ      UDI information must be presented in both human-readable text and AIDC (Automatic Identification and Data Capture) formats.

Manufacturers must submit UDI data to the U.S. FDA Global Unique Device Identification Database (GUDID) following proper formatting guidelines.

Remember that different regulations apply in each country.

Contact us today to discover how our medical device label compliance and UDI services can benefit your business.

KGMP simplifies compliance with complex cosmetic regulations.

K-GMP supports clients in ensuring the quality, safety, and performance of their supply chains while complying with local and global regulations, from ingredients to final cosmetics.     

The Global KGMP network offers a comprehensive range of one-on-one customized consultancy support for all types of cosmetic products. We are committed to staying up-to-date with regulatory environments, trends, and industry requirements.

For detailed information about our cosmetic regulation compliance services, please contact our expert directly.

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