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:  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  Manufacturer and Commercial Data  Technical Specifications  Additional Requirements  UDI Issuing Entities  UDI-DI and UDI-PI numbers must be issued by specific authorized entities:  How Medical Device Consulting Companies Can Support Implementation  Registration and Notification Support  Medical device consulting companies can assist businesses by:  Documentation Preparation  Consultants can help prepare essential documentation including:  Considerations for Software and SaMD  For Software as a Medical Device (SaMD) products, special attention must be given to:  Implementation Strategy for Different Company Types  For Manufacturers  For Importers and Distributors  Similar to FDA registration processes, importers should:  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  Long-Term Strategic Planning  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.    Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br