For medical device studies in Chile, the protocol faces one reviewer: an accredited Ethical-Scientific Committee (Comité Ético Científico, CEC). The Ministry of Health does not review the protocol — the single ethics gate, with a 45-day decision clock, is the fastest first-in-human path in the region for devices.
Chilean law — Law 20.120 on scientific research in human beings and its regulation, Supreme Decree (Decreto Supremo) 114 of 2010 — requires every clinical study in human beings to pass ethical-scientific review by an accredited Ethical-Scientific Committee before it starts. For medical device investigations, that committee review is the protocol's only gate: the Ministry of Health does not review the device protocol itself.