FDAnews Device Daily Bulletin

Brazil Doubles License Registration Timeframe for High-Risk Devices, IVDs

Feb. 6, 2018

Brazil’s National Surveillance Agency has extended the registration period for high-risk Class III and Class IV devices and in vitro diagnostics from five years to 10 years.

Licenses already granted in Brazil will be automatically awarded the 10-year extension, which became effective Jan. 22.

ANVISA made the decision to extend the license period on Jan. 16 after consulting with the ANVISA board of directors and industry. The authority had announced in August 2017 that it was considering doubling the registration period for devices and IVDs, saying the move would cut costs for industry and reduce bureaucratic layers.

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