Thinking about selling your medical device in Brazil? If so, you should know that the Brazilian medical device and IVD market is complex. The changing legislative landscape combined with the limited resources at the Brazilian Health Surveillance Agency (ANVISA) often cause frustration for domestic and foreign manufacturers.
But if you are willing to put in the effort, the Brazilian market has potential. In this 9-page white paper, we'll answer your biggest questions about regulatory requirements for medical device manufacturers in Brazil, including:
- What is Brazilian medical device/IVD GMP?
- Who must meet BGMP requirements?
- What is the submission process?
- What does the future hold for GMP requirements in Brazil?
You'll learn all this and more in this white paper.
About the Author:
Michael Dun is a Senior Regulatory and Quality Consultant at Emergo's São Paulo office in Brazil.