Jan 19, 2018
EMERGO SUMMARY OF KEY POINTS:
Brazilian medical device market regulator ANVISA has simplified importation regulations to ease market entry for foreign manufacturers commercializing in the country.
Among other changes, ANVISA Resolution RDC 208/2018 (link in Portuguese) removes requirements that devices imported into Brazil must undergo inspection at sites where they receive product clearance, which should result in faster time to market for affected importers.
Other important changes in the new resolution include:
According to Luiz Levy, Director of QA/RA at Emergo in Brazil, RDC 208/2018 will benefit foreign medical device manufacturers entering the Brazilian market in terms of time and cost.
“This is a great change that simplifies the importation process, helps reduce importation timeframes and reduces costs associated with importation,” Levy says. “We anticipate additional steps from ANVISA in the near future to simplify import licensing requirements using a risk-based approach, which should further benefit foreign manufacturers with good compliance histories.”
EMERGO KEY POINTS:
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: