Brazil proposed mandatory inclusion of UDI / IMDRF standard barcode on traceability tags for cardiological stents, hip and knee implants Brazilian Health Regulatory Agency (Anvisa)proposedmandatory inclusion of UDI / IMDRF standard barcode on traceability tags for cardiological stents, hip and knee implants. The mandatory inclusion of a UDI / IMDRF standard barcode as the technology for capturing, storing and transmitting data on the traceability tags of cardiac stents, hip and knee implants is established for the proper tracking and control to be performed within the scope of the National Registry of Implants - RNI. The bar code referred to in the caput of this article shall comply with the technical standards established by the International Technical Standards ISO and IMDRF, listed in the Annex to this Resolution, in order to ensure the reading by electronic data capture mechanisms throughout the chain of products, minimally during the life of the product. The arrangement of the bar code should not prejudice the visualization of the other information in the current legislation for traceability labels. The inclusion of the traceability labels containing the bar code in the consumer packaging shall be carried out by the holder of the registration or international manufacturer. Product cover: Cardiological stents, hip and knee implants HS code: 90 Proposed date of adoption: NA Proposed date of entry into force: NA Final date for comments: 11-12-2017 | 
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