Chile's device framework is thin by design — and that is the advantage. For a first-in-human device study, an accredited Ethical-Scientific Committee (Comité Ético Científico, CEC) is the protocol's only gate: no Ministry of Health protocol review. Device competence sits with ANDIM (Agencia Nacional de Dispositivos Médicos); the CEC decides on a 45-day clock.
First-in-human work lives or dies on the authorization path, and Chile's path for devices has exactly one protocol reviewer. Under Law 20.120 and Supreme Decree 114 of 2010, an accredited Ethical-Scientific Committee reviews the device protocol and decides within 45 days of submission, extendable once by 20 days for founded reasons. The Ministry of Health does not review the protocol — that single-gate structure is why Chile is bioaccess®'s top first-in-human jurisdiction in Latin America.