Brazil has the largest economy and medical device market in Latin America, but per capita medical expenditure is still very low. The Brazilian market was estimated at CHF 3.8 billion in 2010 with projected growth of more than 10%. Medical devices are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA) and the regulations and classification schemes are similar to those found in Europe. Companies without a local establishment are required to appoint a Brazilian Registration Holder as a liaison with ANVISA. Once the Brazil Registration Holder role is appointed, it controls the registration for your products and cannot be transferred. A Technical File (TF) must be submitted for each product proving it is safe and effective. The Brazilian TF differs from European or FDA applications; however companies whose products already have CE Marking or FDA clearance will have conducted testing that satisfies most of the ANVISA registration requirements. The process of getting a Class I, II or III medical device approved typically ranges from 6-12 months. Good Manufacturing Practices, similar to those in the USA, must also be met, and biennial audits are conducted. 

Human Medical Devices

Our company is ready to Register, Import and Sale Human Medical Devices, we have 

ANVISA authorization (AFE):

PROCESSO: 25351.762944/2010-90 AUTORIZ/MS:G1L64M7HYH44 (8.07644.6)

If you are out of Brazil and are interested to make business here we are available