Understanding the New UDI Requirements of RDC 884/2024
The Brazilian Health Regulatory Agency (ANVISA) has set new deadlines for the implementation of Unique Device Identification (UDI) through RDC 884/2024, marking a significant milestone in medical device regulatory compliance in Brazil. This comprehensive guide will help manufacturers, importers, and distributors understand the implementation timeline and prepare for compliance.
Implementation Schedule by Risk Class
RDC 884/2024 establishes specific deadlines based on the risk classification of medical devices:
- Class IV (High Risk): July 10, 2025 (3.5 years)
- Class III: January 10, 2026 (4 years)
- Class II: January 10, 2027 (5 years)
- Class I (Low Risk): January 10, 2028 (6 years)
Essential UDI Data Elements for the ANVISA Database
According to the regulatory framework, registration or notification holders must provide comprehensive information to the UDI database, including:
Core Product Information
- Quantity per packaging configuration
- Device UDI-DI and its issuing entity for each packaging level
- Method of production control: serial number, lot number, expiration date, or software version
- Unit of Use UDI-DI (when applicable)
- GMDN (Global Medical Device Nomenclature) Code
Manufacturer and Commercial Data
- Manufacturer’s name and address with customer service information
- Trade name as indicated by the manufacturer
- Commercial model of the device
- Catalog number (optional)
- Clinically relevant dimensional characteristics
Technical Specifications
- Complementary product description (optional)
- Storage and handling conditions as labeled
- Single-use device labeling (yes/no)
- Maximum number of reuses (when applicable)
- Sterile device labeling (yes/no)
- Need for sterilization before use
- Sterilization method (when applicable)
Additional Requirements
- URL for supplementary information (optional)
- Critical warnings or contraindications, including:
- Contains latex (yes/no)
- MRI compatibility (yes/no)
- Other critical warnings
- Device discontinuation date
UDI Issuing Entities
UDI-DI and UDI-PI numbers must be issued by specific authorized entities:
- GS1
- HIBCC (Health Industry Business Communications Council)
- ICCBBA (International Council for Commonality in Blood Banking Automation)
How Medical Device Consulting Companies Can Support Implementation
Registration and Notification Support
Medical device consulting companies can assist businesses by:
- Managing the secondary process for UDI registration after registration/notification approval
- Ensuring compliance with ANVISA Brasília requirements
- Coordinating with authorized UDI issuing entities
Documentation Preparation
Consultants can help prepare essential documentation including:
- Comprehensive UDI data submission forms
- Alignment of technical documentation with RDC 884/2024
- Integration with existing Quality Management System processes
Considerations for Software and SaMD
For Software as a Medical Device (SaMD) products, special attention must be given to:
- Software version tracking
- Release date documentation
- Digital labeling requirements
Implementation Strategy for Different Company Types
For Manufacturers
- Initiate the UDI-DI assignment process immediately.
- Coordinate with packaging and labeling teams.
- Implement tracking systems for production control.
- Ensure integration with GMP compliance.
For Importers and Distributors
Similar to FDA registration processes, importers should:
- Qualify with ANVISA through appropriate documentation.
- Coordinate with manufacturers for UDI data.
- Maintain traceability throughout the distribution chain.
- Ensure proper documentation for each import.
Integration with Existing Regulatory Processes
UDI implementation functions as a secondary process that must be completed after registration/notification approval, similar to the requirements for submitting Instructions for Use (IFU) in Portuguese.
Preparing for Compliance
Immediate Actions Required
- Evaluate your current product portfolio by risk class.
- Identify the UDI issuing entity for your organization.
- Review packaging and labeling systems.
- Assess IT infrastructure for submission to the UDI database.
- Train regulatory teams on the new requirements.
Long-Term Strategic Planning
- Integrate UDI requirements into the product development lifecycle.
- Establish relationships with qualified medical device consulting partners.
- Develop standard operating procedures for UDI maintenance.
- Plan system integration with international UDI requirements.
Conclusion
The implementation of UDI requirements under RDC 884/2024 represents a significant advancement in medical device traceability and patient safety in Brazil. Companies should begin preparations immediately, especially those with Class IV devices facing the July 2025 deadline.
Working with experienced medical device consulting professionals can significantly streamline the implementation process, ensuring compliance while minimizing business disruptions. The key to successful implementation lies in early preparation, a systematic approach, and leveraging the expertise of regulatory consultants familiar with ANVISA requirements.
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