bioaccess® runs first-in-human (FIH) trials in Chile. Chile is our top FIH jurisdiction in Latin America — and the reason is structural: for medical device studies, the protocol faces one gate. An accredited Ethical-Scientific Committee (Comité Ético Científico, CEC) reviews it, with a 45-day review clock extendable once by 20 days (Decreto 114/2010, art. 18, https://www.bcn.cl/leychile/navegar?idNorma=1032919) under Decreto Supremo 114 of 2010. The Ministry of Health does not review the protocol. Device competence sits with ANDIM (Agencia Nacional de Dispositivos Médicos); the Instituto de Salud Pública (ISP) issues the investigational-device import authorization — import paperwork, not a protocol gate. We run trials there — designed with FDA submission in mind under 21 CFR 812.28.
bioaccess® is the First-in-Human CRO for Chile, and Chile is our top first-in-human jurisdiction in Latin America. The reason is structural: for medical device studies, the protocol faces one gate. An accredited Ethical-Scientific Committee reviews it — the Ministry of Health does not review the protocol. Device competence sits with ANDIM (Agencia Nacional de Dispositivos Médicos). The Instituto de Salud Pública (ISP) issues the investigational-device import authorization as a separate logistics step — import paperwork, not a protocol gate. We run trials there — not a named Chilean company we do not list here, and not a country we talk sponsors out of.