By Stewart Eisenhart, Emergo Group
Brazil’s medical device market offers significant growth potential for foreign manufacturers, but the country’s device approval process is challenging.
In this podcast, Emergo Vice President of Business Development Ann Marie Boullie provides an overview of Brazil’s regulatory requirements for medical device registration, including:
- Determining your device classification based on ANVISA recommendations
- Brazil Good Manufacturing Practice (BGMP) quality management system compliance
- INMETRO certification for certain types of medical devices
- Brazil Registration Holder (BRH) authorized representation for foreign manufacturers
Additional Emergo resources for medical device companies interested in the Brazilian market include our video overview of Brazilian registration, our regulatory chart of the ANVISA approval process, and our whitepaper on BGMP QMS implementation.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.