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Brazil moves to reform device group registration with new traceability & labelling rules

This article was originally published in Clinica

Executive Summary

Brazil is reforming the system for registering medical device "product groupings". Draft regulations issued for public consultation seek to address the "need to establish new criteria on how medical devices are organised and grouped" for the purpose of registration with healthcare surveillance agency Anvisa - or their exemption from this; they also, crucially, redefine the concepts of product families, kits/sets, systems and stand-alone products.

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