Brazil ANVISA Medical Device Regulations

Overview of Brazil ANVISA medical device regulations

Medical and in vitro diagnostic (IVD) device manufacturers need to obtain approval from Agência Nacional de Vigilância Sanitária (ANVISA) prior to selling their products in Brazil. 

Brazil ANVISA medical device regulatory approval process 

The chart illustrates the ANVISA approval process per device classification in Brazil and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a condensed overview of the main steps for registration is provided here. 

Step 1 
Determine the classification of your device according to ANVISA’s classification rules.  

Step 2 
Appoint a Brazil Registration Holder (BRH) to manage your device registration and interact with ANVISA on your behalf.  

Step 3 
Certain devices require in-country analysis/certification such as INMETRO certification. If applicable, the in-country analysis/certification must be obtained before registering the device with ANVISA. 

Step 4 
All manufacturers must comply with Brazilian Good Manufacturing Practice (B-GMP) requirements. If you have a higher-class device, you must undergo an audit and obtain certification from ANVISA for B-GMP compliance. 

Step 5 
Prepare the application forms and a technical dossier for submission to ANVISA. 

Step 6 
Pay the application fee. ANVISA reviews the application and may request additional information. 

Step 7 
Upon approval, ANVISA issues the notification/registration number for your device.