Stewart Eisenhart, of massdevice.com, explains that Brazilian medical device regulator ANVISA is planning a multitude of updates and revisions to Brazil’s existing regulatory system to be enacted by the end of 2014. These proposed changes will affect almost all quality management system requirements and registrations currently in place. Although none of the alterations have been enacted yet, the announcement of a list of medical device and in vitro diagnostic issues targeted displays ANVISA’s plan is coming to fruition. If all the changes are to be enacted by the end of 2014, Brazil will have more efficient, cost effective market access for foreign manufacturers. Do you think Brazil could begin to be a major player in foreign manufacturing in the next five years? For the full article click here.
