Brazil
16 articles
IVD Registration Compared: FDA 809, EU IVDR, China, Brazil & India
Side-by-side legal-text comparison of IVD registration: FDA 21 CFR Part 809, EU IVDR 2017/746, China SAMR Decree 48, Brazil RDC 830/2023, India MDR 2017 — classes, pathways, who reviews.
Adverse-Event Reporting Compared: FDA 21 CFR 803, EU MDR, Brazil, Thailand & SA
Side-by-side legal-text comparison of device adverse-event reporting: FDA 21 CFR 803, EU MDR Art. 87, Brazil RDC 67/2009, Thailand MoPH, SAHPRA — triggers, timelines, who must report.
QMS/GMP Compared: FDA QMSR, Brazil RDC 665, Mexico NOM-241 & China
Legal-text comparison of medical device quality systems: FDA 21 CFR Part 820 (QMSR), Brazil RDC 665/2022, Mexico NOM-241-SSA1-2025, and China Order 53 — scope, certification, and audit.
Recall vs FSCA Compared: FDA 21 CFR 806, EU MDR, Brazil & Thailand
Side-by-side legal-text comparison of medical device field actions: FDA 21 CFR Part 806, EU MDR FSCA/FSN, Brazil RDC 551/2021, and Thailand recall guidance — triggers, timelines, filing objects.
Software as a Medical Device (SaMD) Regulation Compared: SFDA, ANVISA, NAFDAC, PPB
Compare how Saudi SFDA MDS-G23, Brazil ANVISA RDC 657/2022, Nigeria NAFDAC and Kenya PPB regulate Software as a Medical Device — definitions, risk classes, and filing routes.
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.
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 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.
Borderline Product Classification Across FDA, EU MDR, ANVISA, and COFEPRIS
How to classify hand sanitizer, mouthwash, personal lubricants, and data recorders as medical devices or non-devices across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS.
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.
Global CE Mark Reliance Map for Medical Device Manufacturers
See where CE marking supports device approvals across 25+ markets, including full reliance, abridged review, evidence acceptance, and remaining local steps.
Brazil SUS Medical Device Procurement: Public Healthcare System Market Access Guide (2026)
Guide to Brazil SUS medical device procurement, covering Law 14,133/2021, CONITEC health technology assessment, Compras.gov.br e-procurement, foreign supplier requirements, pricing, and market entry.
Medical Device Regulatory Consulting Hourly Rates by Region (2026)
Benchmark medical device regulatory consulting rates by region and consultant tier, with cost drivers and budgeting guidance for registration projects in major markets.
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.
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.