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Brazil's Anvisa hits two firms over regulatory failures

This article was originally published in Clinica

Executive Summary

Brazilian medtech distributor HS Biosystem Produtos Hospitalares is one of two companies barred last week by regulatory agency Anvisa from operating. The São Paulo-based importer "no longer meets the requirements related to the importation, storage and distribution of medical supplies", according to the Brasilia-based agency, which has ordered the removal of its entire range of products from the market. Similarly, commercial-regulatory breaches by Audtec Comércio de Aparelhos Auditivos (Campinas, São Paulo state) led Anvisa to halt "manufacture, trade and use of some of its products", notably audiometric equipment.

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