Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 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