Mexico
11 articles
US Medical Device Imports Teardown: Why Mexico — Not China — Is America's #1 Source
A data-driven teardown of US medical device imports using the CEPII BACI dataset, analyzing the difference between core devices and the PPE/consumables basket.
Mindray Worldwide Market-Access Footprint: 24-Market Registry Teardown
A comprehensive database analysis detailing Mindray's 6,620 distinct registrations across 24 global markets, including patient monitoring accessories, IVD, and ultrasound segments.
GE HealthCare FDA Device Footprint: Clearances, PMA & Recalls Guide
A data-driven regulatory profile of GE HealthCare's FDA clearances, PMA approvals, safety recalls, and offshore manufacturing hubs in India, Mexico, and Finland.
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.
UDI & Labeling Compared: FDA 801/830, EU MDR, Mexico NOM-137 & China
Legal-text comparison of medical device UDI and labeling: FDA 21 CFR Parts 801 & 830, EU MDR Article 27/Annex VI, Mexico NOM-137-SSA1-2025, and China Order 6/2014 — carriers, databases, and language.
Mexico COFEPRIS Registration Holders: 5,286 Holders and the 2024 Volume Surge
Analysis of Mexico's 16,473 COFEPRIS registrations reveals 5,286 holders, 60% single-registration, diagnostics dominance at 37%, and a 2024 record peak.
Mexico Medical Device Registration Cost: MRH Pricing Guide (2026)
Compare Mexico MRH pricing models for medical device registration, including flat fees, hourly billing, three-year cash flow scenarios, switching steps, RFP points, and COFEPRIS pathways.
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.
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.
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.
Mexico COFEPRIS Medical Device Registration: The Complete Guide
Register medical devices with Mexico COFEPRIS, including classification, standard and equivalency routes, registration holder duties, fees, fast-track options, and 2026 market entry planning.