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 (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. 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.