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Brazil moves to standardise device nomenclature and labelling

This article was originally published in Clinica

Executive Summary

Brazil is considering using a translation of the Global Medical Device Nomenclature (GMDN) as the basis of its "common denomination of healthcare products" (DCB-PS). The plans are subject to two brief consultations, currently under way: one relates to the list of terms themselves; the other, to technical considerations, such as: the forms to apply for the inclusion, alteration or removal of terms from the DCB-PS list, and labelling requirements. The proposals (published officially in the May 15 Di�rio Oficial da União) can be accessed via the Anvisa website (www.anvisa.gov.br); the consultations are scheduled to end on June 15.

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