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 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.