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Anvisa

Brazilian regulators allow more flexibility for device registration transfers, extend tech file deadline

July 19, 2016 By MassDevice

By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has signaled that a new regulation providing more flexibility for transferring medical device registrations between holders. At a recent ANVISA meeting attended by Emergo consultants, the agency announced that agreement on the final contents of the new device ownership transfer rule has been reached; […]

Filed Under: Regulatory/Compliance Tagged With: Anvisa

Sientra hits 52-week low on Brazil’s Silimed implant ban

October 5, 2015 By Brad Perriello

Shares of Sientra (NSDQ:SIEN) plunged a further 20% today to a 52-week low after Brazilian regulator Anvisa last week suspended the production, sale and use of products made by Brazil’s Silimed, Sientra’s sole supplier of breast implants. The news follows a decision last month by the U.K.’s Medicines & Healthcare Products Regulatory Agency to suspend sales of Silimed implants, including breast, […]

Filed Under: Cosmetic/Aesthetic, Regulatory/Compliance, Wall Street Beat Tagged With: Anvisa, Medicines & Healthcare products Regulatory Agency (MHRA), Sientra, Silimed

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