Mexico
5 articles
Mexico Medical Device Registration Cost 2026: MRH Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
Pure Global publishes Mexico MRH service at $2,000/year flat for Class I and $3,000/year for Class II/III — versus $15,000–$30,000 Year 1 under hourly billing. A buyer-side breakdown of Mexico Registration Holder (MRH) pricing models with 3-year cash flow scenarios, switching playbook, and RFP template for COFEPRIS submissions and the Equivalence Pathway.
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.
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.
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.
Mexico COFEPRIS Medical Device Registration: The Complete Guide
How to register medical devices with Mexico's COFEPRIS — classification, standard and equivalency routes, Mexico Registration Holder requirements, fees, the new 30-day fast-track pathway, and practical market entry guidance for 2026.