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

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.

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.

Anvisa's proposals, published in the Diario Oficial da Uniao (DOU) of March 6 (downloadable also from the Anvisa website, www.anvisa.gob.br), would require all grouped devices to have a: "common manufacturer...

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