ANVISA
6 articles
MDSAP in 2026: Revised Audit Approach, TGA Migration, and Post-QMSR Value
A strategic evaluation of MDSAP in 2026: analyzing the February 2026 revised audit approach, the TGA mdsap.global migration, and a post-QMSR ROI decision framework.
Why FDA or CE Clearances Fail to Register Aesthetic Devices in China, Korea, and Brazil
A deep regulatory analysis of aesthetic device classification and registration pathway divergence across the US, EU, China, South Korea, and Brazil, mapping sequencing strategies and all-in costs.
Brazil Medical Device Registration Cost: BRH Pricing Guide (2026)
Buyer-side guide to Brazil medical device registration costs, BRH pricing models, hourly versus flat fees, and 3-year cash flow for Class I/II notifications and Class III/IV registrations.
Brazil ANVISA Registration Trends and Market Access Data (2024-2025)
Original analysis of 111,000+ ANVISA medical device registrations, showing Brazil market trends, leading registration holders, category shifts, and market entry strategy.
Brazil ANVISA Medical Device Cost Breakdown: Fees and Add-Ons (2026)
2026 Brazil ANVISA device cost guide with government fees by class, BGMP audit costs, MDSAP carve-outs, ANATEL and INMETRO add-ons, and Brazilian Registration Holder retainers.
LATAM Medical Device Registration: Country-by-Country Comparison Guide (2026)
Compare medical device registration in Brazil, Mexico, Colombia, Argentina, Chile, and Peru, including classification, timelines, fees, local reps, pathways, and 2026 updates.