ANVISA
4 articles
Brazil Medical Device Registration Cost 2026: BRH Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in Brazil in 2026? A buyer-side breakdown of Brazilian Registration Holder (BRH) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class I/II notifications and Class III/IV registrations.
Brazil Medical Device Market Deep Dive: ANVISA Registration Trends, Data Analysis & Market Access Strategy (2024-2025)
Original data analysis of 111,000+ ANVISA medical device registrations reveals market trends, fastest-growing registration holders, product category shifts, and optimal market entry strategies for Brazil.
Brazil ANVISA Medical Device Cost Breakdown 2026: Exact Fees for Classes I-IV, BGMP Audit Schedule, MDSAP Carve-Outs, ANATEL/INMETRO Add-Ons
The definitive 2026 cost reference for ANVISA medical device registration — exact government fees by class in BRL and USD, BGMP audit costs and schedules, MDSAP carve-outs, ANATEL wireless fees, INMETRO electrical safety certification, and Brazilian Registration Holder retainer ranges.
LATAM Medical Device Registration: Country-by-Country Comparison Guide (2026)
A comprehensive comparison of medical device registration requirements across Latin America's six major markets — Brazil (ANVISA), Mexico (COFEPRIS), Colombia (INVIMA), Argentina (ANMAT), Chile (ISP), and Peru (DIGEMID) — covering classification, timelines, fees, pathways, and 2026 regulatory updates.