Chile is a natural venue for cardiovascular device first-in-human work: for medical device studies, an accredited Ethical-Scientific Committee (Comité Ético Científico, CEC) is the only protocol gate — no Ministry of Health protocol review — with a 45-day decision clock. Pair the ethics pathway with a cardiovascular surgical center, and the device FIH has its structure.
A cardiovascular device trial — a valve, an implant, a catheter-based system — needs two things in Chile: the right ethics pathway and the right facility. The pathway is the national device advantage: for medical device studies, an accredited Ethical-Scientific Committee is the only protocol gate, the Ministry of Health does not review the protocol, and the committee decides within 45 days of submission (extendable once by 20 days for founded reasons, Supreme Decree 114 of 2010).