By Stewart Eisenhart, Emergo Group
Brazilian medical device market regulator ANVISA has set institutional performance targets through June 30, 2014 under Ordinance No. 1.058. (Link in Portuguese)
The Ordinance sets 16 performance goals for the regulator to meet over the next year.
Among these targets:
- Reducing the time to accept or reject importations into Brazil to five working days
- Publication of all operating permits within 60 days
- Issuing first analyses of cadastro and registro medical device petitions within 90 days
Medical device registration in Brazil has proven a complicated and lengthy endeavor for some foreign manufacturers following the market’s rapid growth. If ANVISA can meet these performance targets over the next 12 months, the regulator will have added some welcome transparency and expediency to the Brazilian registration process.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.