Deadline for UDI Implementation
Marcelo Brisolla
CEO I Senior Executive I Legal Expert | Regulatory Affairs I Healthcare I Medical Devices I Environmental Health Consultant I BPO in RA I Services I ANVISA
?? Attention Medical Device Manufacturers: Deadline for UDI Implementation! Resolution RDC 591/2021 marks a significant advancement in the traceability of class IV medical devices in Brazil. The Unique Device Identification (UDI) system is already a reality, and the implementation deadline for some products is approaching!
?? Important Reminder
By July 2024, class IV medical devices must include UDI on their packaging, ensuring precise identification and traceability throughout the supply chain.
What to do?
Assign and apply UDI to your products' packaging. Prepare to provide information to the UDI database and in adverse event reports (for this, the publication of regulatory instructions is still necessary; however, ANVISA does not yet have a timeline for the publication of these instructions, as they depend on the completion of the UDI system (platform for data submission), which is being developed by ANVISA's IT team).
This is an important step to improve patient safety and optimize product management.
?? Read the full article on our website by clicking the link. https://lnkd.in/d4CMaZms
Still have questions about how to proceed? Our experts are available to guide and support your company in this process.