Brazil & LATAM Market Access
Bring your device to Brazil without learning ANVISA the hard way.
Brazil is Latin America’s largest medical-device market, and its pathway looks nothing like the FDA’s. Registrations run through ANVISA, electrical and metrological conformity through INMETRO, and wireless functions through ANATEL — separate authorities with distinct evidence expectations, all in Portuguese.
U.S. manufacturers routinely underestimate this, commit to a launch timeline, and then discover the pathway they assumed does not exist. AVRA helps define a viable route before resources and commercial commitments are locked in.
AVRA supports
- ANVISA classification and registration pathway assessment
- Technical dossier preparation and review against ANVISA expectations
- INMETRO / DIMEL conformity strategy, including metrologically sensitive devices
- ANATEL certification coordination for connected and wireless devices
- Portuguese-language labeling and IFU adaptation
- Brazilian Registration Holder and technical responsibility guidance
- Realistic timeline and cost mapping before commercial commitments
Experience behind the service
Experience as a formally designated Technical Responsible before ANVISA, including responsibility during regulatory inspections and post-market vigilance.