bioaccess® runs early feasibility studies (EFS) in Chile. For medical 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 — this one-gate path is device-only; drug and biologic trials follow a different authorization path. 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.
bioaccess® runs early feasibility studies in Chile, and Chile is our top early-feasibility jurisdiction in Latin America for medical devices. 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), and 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.