Chile regulates clinical research through a compact, readable framework: Law 20.120 and Supreme Decree 114 of 2010 govern ethics review; the Sanitary Code's article 111A anchors device investigations; ANDIM (Agencia Nacional de Dispositivos Médicos) holds device competence; and Law 20.850 sets post-trial duties. For medical device studies, the framework has one protocol gate — the accredited ethics committee.
Chile's clinical-trial regulation is unusually legible. Law 20.120 establishes the ethical-legal foundation for scientific research in human beings, and its regulation — Supreme Decree (Decreto Supremo) 114 of 2010 — sets the operating rules, including the accredited Ethical-Scientific Committee's 45-day decision clock, extendable once by 20 days for founded reasons. Committees are accredited by the SEREMI de Salud (regional health authority).