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QUOTED. 4 July 2019. Walban Damasceno de Souza.

Executive Summary

Anvisa – Brazil's medical technology regulatory agency – has enacted a regulation that allows new devices that are sterilized using ethylene oxide to be certified as sterile under a parametric release protocol. See what Walban Damasceno de Souza of medtech industry association ABIMO said about it here.

“This is a great victory for our industry, which has been suffering from outdated legislation, compared with most other countries. All companies, from the largest, with their own sterilization facilities, to the smallest, which rely on outsourced services, will benefit immediately.” – Walban Damasceno de Souza, senior adviser, ABIMO

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