Colombia
3 articles
Colombia Medical Device Registration Cost 2026: INVIMA Representative Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in Colombia in 2026? A buyer-side breakdown of Colombia Representative (Representante Legal) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class I/IIa uncontrolled and Class IIb/III controlled pathways.
Colombia INVIMA Medical Device Registration: Complete Guide for Foreign Manufacturers (2026)
Everything you need to know about INVIMA medical device registration in Colombia — covering classification (Classes I–III), uncontrolled vs controlled pathways, Decree 4725 requirements, UDI-DI compliance, fees, timelines, legal representation, and post-market surveillance obligations for 2026.
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.