Resources
All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.
Brazil ANVISA Regulatory Approval Process for IVDs
Manufacturers need to obtain ANVISA ( Agência Nacional de Vigilância Sanitária ) approval prior to selling their products in Brazil. Brazil has four
Medical device registration process in Brazil
Interested in selling your medical device in Brazil? Brazil's device registration process is well established, but rather complex. It's important to
In Depth: Brazil Medical Device Approval and Compliance
Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK.
WATCH NOW: Brazil ANVISA Medical Device Registration
Brazil’s medical device industry faced a number of challenges in recent years: a complex regulatory process created long delays for approvals and a
Brazil QMS Requirements For Medical Device Manufacturers
Thinking about selling your medical device in Brazil? If so, you should know that the Brazilian medical device and IVD market is complex. The
Introduction to Brazil's Medical Device Approval Process
Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK.
Get smart about Brazil in 1 hour
If you are thinking about entering the Brazilian market for the first time, understanding ANVISA’s regulatory requirements can be overwhelming.
What To Expect From Your Regulatory Representative
Are you hoping to export your device to other medical device markets? If so, most countries require you to appoint an in-country representative if