As an important emerging market that has captured the attention of foreign medical device manufacturers, Brazil currently imports 60% of its medical equipment, amounting to US$1.9 billion. With 200 million inhabitants, an Unified Health System (SUS) and an estimated 36 million Brazilians ascended into the middle class within the past four years, public and private partnerships are necessary to increase the access to a better standard of care demanded by the Brazilian people.
However, this attractive market also shows some challenges. This is especially true when it comes to registration and certificates system, audits processes, administrative and import obstacles. ANVISA is Brazil’s National Health Surveillance Agency that suffers from processes delays and lack of professionals. Some initiatives have already happened in order to facilitate registration processes and market access, as the Memorandum of Understanding that was signed by U.S., Canadian and Australian Notified Bodies with their Brazilian counterparts in 2012.