Medical device trials in Panama run through a dedicated review channel in MINSA's Dirección Nacional de Dispositivos Médicos, with hard ethics clocks under Decreto Ejecutivo 21 and investigational-device import on the Ley 90 research exception. bioaccess® is the device-trial CRO on that file.
Medical device clinical trials in Panama are reviewed through a dedicated device-trial channel in the Dirección Nacional de Dispositivos Médicos (National Directorate of Medical Devices) within MINSA (Ministerio de Salud). That channel exists because Panama's 2026 framework — Decreto Ejecutivo 21 of 23 April 2026, implementing Ley 84 of 14 May 2019 — treats device investigations as their own review track, with hard ethics-review clocks through accredited Type II committees and parallel MINSA technical evaluation for higher-risk protocols.