ANVISA medical device registration for FDA-cleared and CE-marked products entering Brazil. 60–180 day published timeline, Class III/IV BGMP audit handled, single all-inclusive annual fee.
60–180 days
Brazil allows multiple importers on a single ANVISA registration but only with the registration holder’s cooperation. bioaccess® holds the registration through our own Brazilian entity.
First device family low-to-mid risk USD 7,500/yr; Class III/IV USD 12,000/yr. Additional families +USD 3,500 (low/mid) or +USD 5,500 (Class III/IV) per year.
All-inclusive annual subscription includes government submission fees, in-country registered agent, regulatory liaison, and certified/sworn translations where required. Electrical/EMC and RF homologation for wireless devices are handled through the country’s telecom authority at vendor cost plus a 20% G&A handling fee.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Brazil.