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Posted 26 January 2015 | By Stewart Eisenhart,
Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
A new Brazilian law allows ANVISA, the country’s medical device market regulator, greater latitude to manage public health risks and surveillance measures in a way that may also boost efficiencies for Brazilian market registrants.
Chapter X of the new Law 13,097/2015 (link in Portuguese) includes the following changes to the existing ANVISA regulatory process:
Although the new law has already been published, ANVISA will need to release regulations that further define and implement the allowances made in the law.
To learn more about medical device registration and approval requirements in Brazil, view our Brazil Medical Device Registration Overview video.
Original Post at Emergo
Related Post: Brazil relaxes BGMP requirements for manufacturers holding INMETRO certification
Related Post: Australia, Brazil, Canada and US Plan Shared Medical Device Audit Program
Tags: Emergo, Brazil
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