Brazil
11 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.
MDSAP Audit Preparation: Complete Guide for Medical Device Manufacturers (2026)
Everything you need to prepare for an MDSAP audit — the 2026 updated audit approach (AU P0002.010), QMSR alignment, step-by-step preparation checklist, costs, timelines, and common nonconformities.
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.
Is It a Medical Device? Borderline Product Classification for Hand Sanitizer, Mouthwash, Personal Lubricants & Data Recorders Across FDA, EU MDR, Brazil ANVISA and Mexico COFEPRIS
How to classify four common borderline products — hand sanitizer, mouthwash, personal lubricants, and data recorders — across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS. Includes decision trees, regulation citations, and jurisdiction-by-jurisdiction comparison tables.
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.
Where Does Your CE Mark Actually Get You? The Global Reliance Map for Medical Device Manufacturers
A strategic map of 25+ countries where CE marking provides regulatory leverage — organized by mechanism: full reliance, abridged review, evidence-only acceptance, and reference-only. Know which markets your CE Mark unlocks and what extra steps remain.
Brazil SUS Medical Device Procurement: Public Healthcare System Market Access Guide (2026)
How Brazil's SUS public healthcare system procures medical devices — covering the legal framework (Law 14,133/2021), CONITEC health technology assessment, e-procurement via Compras.gov.br, requirements for foreign suppliers, pricing mechanisms, and strategic recommendations for market entry.
Medical Device Regulatory Consulting Hourly Rates by Region (2026)
Transparent benchmark of medical device regulatory consulting fees across 16 countries and regions — covering hourly rates by consultant tier, factors that drive cost, and how to budget for registration projects in the US, EU, Japan, Korea, China, India, Brazil, Saudi Arabia, and more.
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.
Brazil ANVISA Medical Device Registration: The Complete Guide
How to register medical devices with ANVISA — classification, B-GMP via MDSAP, registration pathways, documentation, fees, and practical guidance for the Brazilian market.
MDSAP Audit: The Complete Guide to the Medical Device Single Audit Program
Everything about MDSAP — the single audit program covering FDA, Health Canada, TGA, ANVISA, and MHLW. Audit process, grading, preparation, costs, and how to pass.