Chile

A complete guide to registering medical devices in Chile through ISP (Instituto de Salud Pública). Covers the four-class risk system, GICONA registration platform, documentation requirements, fees, timelines, and the new March 2026 decree expanding mandatory registration to 39 additional device categories.

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.