bioaccess® runs medical device clinical trials in Chile. For device studies, the protocol faces one gate: an accredited Ethical-Scientific Committee (Comité Ético Científico, CEC) reviews it, with a 45-day decision 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. Devices are classified in classes I–IV. We run trials there.
bioaccess® runs medical device clinical trials in Chile, and Chile is our top device-trial jurisdiction in Latin America. For device studies, the protocol faces one reviewer: an accredited Ethical-Scientific Committee. 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.