Pilot and feasibility studies are where device designs get their first human answers — and Chile is built for exactly that. For medical device studies, an accredited Ethical-Scientific Committee (Comité Ético Científico, CEC) is the only protocol gate, with a 45-day decision clock: small, iterative, learning-focused studies move without a ministry queue.
A pilot study asks narrow questions — does the device deploy as designed, what does first human use reveal, which design iteration comes next — and it needs a regulatory path proportionate to those questions. Chile's device path is exactly that: for medical device studies, the protocol goes to one reviewer, an accredited Ethical-Scientific Committee, and the Ministry of Health does not review the protocol. The committee decides within 45 days of submission, extendable once by 20 days for founded reasons (Supreme Decree 114 of 2010).