Following some of our latest results in emerging markets, the Brazilian healthcare market is still poised for rapid growth from 2011-2015 with a compound annual growth rate of 12.6%. Because of the healthy market, many manufacturers are looking to introduce their new products. Brazil however, offers unique challenges when introducing new products. A good local business partner is key.
The Brazilian market for medical devices and pharmaceuticals is monitored by the Health Surveillance Agency, or Agência Nacional de Vigilância Sanitária (ANVISA). All new products need to be authorized and validated by ANVISA. It is customary to find a local partner that has already required certificates such as company working allowance (AFE), facility operation license (LF) and relevant Brazilian Good Practices certificates. The second step would be to get a product classification from a local expert. Additionally, Good Manufacturing Practices (GMP) audits and INMETRO certification need to be acquired for those devices answering specific criteria. This would be followed by preparing and translating all required documents, like labeling, sales certificates as well as product description, and submitting a formal application to ANVISA. After publication and market clearance, a registration with ANVISA is valid for 5 years.
Due to the fact that an ANVISA approval is not transferable to another partner, selecting a reliable business partner in Brazil is of great importance. The approximate time frame for registration ranges from 3 months to a year, dependent on the product classification.