The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
Medical device market regulators in Brazil are planning several updates and revisions to their existing regulatory system through late 2014 that could affect nearly all major registration and quality management system requirements in the country, Emergo Group has learned.
Brazilian medical device regulator ANVISA has drawn up a list of medical device and in vitro diagnostic (IVD) issues targeted for revision:
None of these revisions has yet occurred, however, and there's no guarantee ANVISA will implement all of its planned changes by the end of 2014. Still, the regulator's announcement illustrates which areas of the Brazilian medical device and IVD registration system ANVISA would most likely revise in the near future. Clearer registration pathways for IVD and software products as well as more streamlined BGMP requirements, if enacted, could lead to more efficient and cost-effective market access for foreign manufacturers.