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.
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